Dossier Preparation Jobs in Hyderabad
16 Jobs Found
Sr. Associate Regulatory Affairs
Amgen Inc
Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master s degree OR Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms Qualification : Bachelors degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Accounts Manager
Yalavarti Projects
Job Description: Accounts Executive Experience: 3+ Years Qualification: B.Com (Mandatory), MBA, IPPC/ICWA (Preferred) Job Description: We are seeking an experienced Accounts Executive with a strong background in handling accounting and finance functions. The ideal candidate will have at least 3 years of experience in accounting, GST and tax return filings, and finalization of books of accounts. This role will also involve managing day-to-day financial transactions, ensuring statutory compliance, and working closely with auditors. Key Responsibilities: GST Returns and Tax Filings: Filing GST returns and ensuring timely compliance with GST regulations. Filing Income Tax and TDS returns, ensuring compliance with tax laws and deadlines. Finalization of Books of Accounts: Finalize books of accounts at the end of each financial period, ensuring accuracy and completeness. Rectify accounting entries and verify the books to ensure compliance with accounting standards. Invoicing and Payments: Preparation of invoices and ensuring timely dispatch to clients. Monitor daily cash and bank payments and receipts, ensuring proper accounting of transactions. Monitor and process tour bills as per the company s travel policy. Reconciliation: Perform regular reconciliation of client billing, ensuring all payments are followed up and accounted for. Monitor sundry creditors payments and reconcile creditor accounts. Prepare and manage Bank Reconciliation Statements to ensure all bank transactions are accurately reflected. Statutory Compliance: Ensure compliance with statutory requirements such as Professional Tax, Provident Fund, and other legal obligations. Coordinate with internal and statutory auditors during audits and provide necessary information. Other Responsibilities: Assist in preparing financial statements and reports as required. Review financial transactions for accuracy and ensure all required records are maintained. Address discrepancies and ensure smooth processing of payments and receipts. Qualifications and Skills: Experience: Minimum 3 years of experience in accounting roles, with exposure to GST, tax returns, and finalization of accounts. Technical Skills: Proficiency in Tally (all versions) for accounting functions. Familiarity with GST Returns Filing, Income Tax, TDS, and other statutory compliance procedures. Strong understanding of accounting principles and the ability to finalize books of accounts. Reconciliation and Documentation: Experience in preparing and managing Bank Reconciliation Statements. Expertise in monitoring and following up on client billing and payments. Communication and Coordination: Strong communication skills to interact with clients, auditors, and internal teams. Ability to handle statutory audits and coordinate with auditors. Education: B.Com degree is mandatory. MBA, IPPC, or ICWA qualifications are preferred. Other Skills: Strong attention to detail and accuracy in financial documentation. Ability to work independently and handle multiple tasks efficiently. What We Offer: Competitive salary and benefits. Opportunity for career growth in a dynamic and expanding organization. A collaborative work environment focused on professional development. Qualification : B.Com degree is mandatory. MBA, IPPC, or ICWA qualifications are preferred.
Executive Assistant To The Vice President, Product & Engineering
Zeta
Job Title: Executive Assistant to the Vice President, Product & Engineering Location: Hyderabad, India Job Type: Full-time About Zeta Zeta is a next-gen banking tech company revolutionizing the way banks and fintechs launch modern banking products. Founded in 2015 by Bhavin Turakhia and Ramki Gaddipati, Zeta s flagship product, Tachyon, is the world s first modern, cloud-native, fully API-enabled banking stack. With over 20 million+ cards issued globally, Zeta partners with some of the largest banks and fintechs to modernize customer experience and core banking infrastructure. Backed by SoftBank, Mastercard, and other top-tier investors, Zeta is valued at $1.5 billion, with a workforce of 1700+ employees (70% in R&D), spread across the US, EMEA, and Asia. Role Summary Zeta is looking for a proactive, organized, and detail-oriented Executive Assistant to support the Vice President of Product and Engineering. This role is based in Hyderabad and requires a high level of professionalism, efficiency, confidentiality, and the ability to manage multiple responsibilities in a dynamic, global environment. Key Responsibilities Manage and coordinate a dynamic calendar: appointments, meetings, and global conferences. Handle end-to-end travel arrangements: visas, flights, accommodation, transport, etc. Serve as a point of contact for internal teams and follow up on cross-functional action items. Draft, manage, and respond to professional emails and communication with internal and international stakeholders. Track project statuses and ensure the VP is informed of updates and deadlines. Conduct research and prepare briefing notes and reports as needed. Ensure confidentiality and discretion in handling sensitive information. Organize and manage key events, meetings, and social gatherings. Support on project management tasks, including timelines, documentation, and coordination. Stay updated with industry trends relevant to the product and engineering domains. Skills & Attributes
Ai/ml Developer
Infor
Summary: As an AI/ML Developer, you ll play a pivotal role in creating and delivering cutting-edge enterprise applications and automations using Infor s AI, RPA, and OS platform technology. Your mission will be to identify innovative use cases, develop proof of concepts (PoCs), and deliver enterprise automation solutions that elevate workforce productivity and improve business performance for our customers. Title: Software Engineer Experience: 2-5 years. Skill: AI/ML, Python, AWS, SQL Location: Hyderabad Key Responsibilities: Use Case Identification: Dive deep into customer requirements and business challenges. Identify innovative use cases that can be addressed through AI/ML solutions. Data Insights: Perform exploratory data analysis on large and complex datasets. Assess data quality, extract insights, and share findings. Data Preparation: Gather relevant datasets for training and testing. Clean, preprocess, and augment data to ensure suitability for AI tasks. Model Development: Train and fine-tune AI/ML models. Evaluate performance using appropriate metrics and benchmarks, optimizing for efficiency. Integration and Deployment: Collaborate with software engineers and developers to seamlessly integrate AI/ML models into enterprise systems and applications. Handle production deployment challenges. Continuous Improvement: Evaluate and enhance the performance and capabilities of deployed AI products. Monitor user feedback and iterate on models and algorithms to address limitations and enhance user experience. Proof of Concepts (PoCs): Develop PoCs to validate the feasibility and effectiveness of proposed solutions. Showcase the art of the possible to our clients. Collaboration with Development Teams: Work closely with development teams on new use cases. Best Practices and Requirements: Collaborate with team members to determine best practices and requirements. Innovation: Contribute to our efforts in enterprise automation and cloud innovation. Key Requirements: Experience: A minimum 3 years of hands-on experience in implementing AI/ML models in enterprise systems. AI/ML Concepts: In-depth understanding of supervised and unsupervised learning, reinforcement learning, deep learning, and probabilistic models. Programming Languages: Proficiency in Python or R, along with querying languages like SQL. Data Handling: Ability to work with large datasets, perform data preprocessing, and wrangle data effectively. Cloud Infrastructure: Experience with AWS Sagemaker or Azure ML for implementing ML solutions is highly preferred. Frameworks and Libraries: Familiarity with scikit-learn, Keras, TensorFlow, PyTorch, or NLTK is a plus. Analytical Skills: Strong critical thinking abilities to identify problems, formulate hypotheses, and design experiments. Business Process Understanding: Good understanding of business processes and how they can be automated. Domain Expertise: Familiarity with Demand Forecasting, Anomaly Detection, Pricing, Recommendation, or Analytics solutions. Global Project Experience: Proven track record of working with global customers on multiple projects. Customer Interaction: Experience facing customers and understanding their needs. Communication Skills: Excellent verbal and written communication skills. Analytical Mindset: Strong analytical and problem-solving skills. Collaboration: Ability to work independently and collaboratively. Educational Background: Bachelor s or Master s degree in Computer Science, Mathematics, Statistics, or a related field. Specialization: Coursework or specialization in AI, ML, Statistics & Probability, Deep Learning, Computer Vision, or NLP/NLU is advantageous. About Infor: Infor is a global leader in business cloud software products for companies in industry specific markets. Infor builds complete industry suites in the cloud and efficiently deploys technology that puts the user experience first, leverages data science, and integrates easily into existing systems. Over 60,000 organizations worldwide rely on Infor to help overcome market disruptions and achieve business-wide digital transformation.
Employee Experience & Retention (EE&R) Manager
Firstsource
Position Title: Employee Experience & Retention (EE&R) Manager About Firstsource: Firstsource Solutions Limited, part of the RP-Sanjiv Goenka Group, is a leading provider of transformational solutions spanning the customer lifecycle in sectors including Healthcare, Banking & Financial Services, Communications, Media & Technology, and more. Through our 'Digital First, Digital Now' approach, we help organizations reinvent operations and reshape business models, delivering valuable moments that matter and gaining competitive advantage. We have a global presence across the US, the UK, India, the Philippines, Australia, Mexico, and South Africa, supporting over 100 top global brands, including several Fortune 500 and FTSE 100 companies. Position Purpose: The Employee Experience & Retention (EE&R) Manager is tasked with overseeing all aspects of Employee Experience and Retention within the aligned process. This role ensures the effective execution of EE&R initiatives within agreed timeframes, supporting the achievement of high employee engagement, retention, and satisfaction throughout the process. Key Responsibilities: Employee Relationship Management & Communication: Employee Relations Support: Act as the primary point of contact for EE&R-related matters, handling queries and grievances effectively and providing ongoing employee relations counsel. Policy Communication: Conduct policy sessions during induction, training, and as part of regular Business-As-Usual (BAU) refreshers. Visibility & Engagement: Maintain a consistent and visible presence on the operations floor to foster employee engagement. Reward & Recognition Management: Lead and manage the Reward and Recognition program, addressing concerns and ensuring timely recognition. Employee Support: Provide assistance to employees and teams by implementing EE&R interventions when necessary. Survey Execution: Ensure the timely execution of ESAT, Dipstick, and 360 surveys, acting on the insights to address any concerns and improve employee satisfaction. Policy Updates: Communicate any policy, procedure, or process changes to relevant stakeholders in the process. Corporate Social Responsibility (CSR): Drive CSR initiatives within the team, fostering a sense of community and purpose. Engagement Activities: Organize fun activities and team-building events to maintain a positive, engaging work environment. One-on-One and Skip-Level Meetings: Regularly meet with Team Leaders, Managers, and employees to address concerns, provide HR updates, and gather feedback. Career Progression & Performance Management: Performance Management Execution: Ensure the smooth execution of the Performance Management Process (annually, bi-annually, and monthly). Internal Job Postings (Lateral Moves): Manage and facilitate internal job postings, supporting employee mobility within the organization. Promotion and Assessment: Organize and manage assessment centers to promote advisors to the next level. Career Development Support: Provide guidance and support for employee career growth and development opportunities. Compliance: Increments & Promotions: Ensure timely handling of employee increments and promotions in alignment with lifecycle approaches. Confirmation Process: Oversee the employee confirmation process after six months of service, ensuring timely and accurate documentation. Payroll Coordination: Collaborate with payroll teams to ensure timely receipt of payroll inputs, sign off, and review before submission to vendors. Background Checks & Compliance: Follow up on background checks and ensure appropriate actions are taken for any unfavorable reports. Headcount & Attrition Reports: Own the preparation of weekly headcount and attrition reports, ensuring accuracy and timeliness. Audit Support: Provide necessary support for effective audits and ensure compliance with organizational standards and regulations. Qualifications & Skills: Communication Skills: Excellent interpersonal and communication skills for effectively managing relationships, engaging with employees, and resolving issues. Organizational Skills: Strong time management and organizational skills, with the ability to prioritize tasks and manage multiple responsibilities efficiently. HR Expertise: Deep understanding of HR policies, employee relations, performance management, and compliance requirements. Conflict Resolution: Proven ability to manage grievances, conflicts, and sensitive employee matters with professionalism and discretion. Employee Engagement: Experience in designing and implementing employee engagement initiatives and activities. Team Collaboration: Ability to work collaboratively with Team Leaders, Managers, and other HR teams to drive results. Compliance Knowledge: Understanding of payroll, background checks, and audit processes, ensuring adherence to compliance standards.
Senior Associate Finance
Iq Eq Regcom Limited
Job Description This role provides support to department activities with specific responsibility for the processing, recording, updating and reconciling information in compliance with established policies and procedures and to prepare and input information for the purpose of generating accounts and management information for IQ EQ group entities. Tasks Process service call requests and issue invoices / credit notes / provide specifications / close Service Agreement Lines etc. Assist with credit control activities. Process, record, update and reconcile accounting transactions from bank and credit card statements, including liaison with team for allocations. Process, record, monitor and settle client disbursements. Handle purchase ledger activities Prepare monthly/quarterly/yearly accounts and other reports for management and group reporting. BS Reconciliations Prepare and submit all tax and other statutory/regulatory returns. Prepare statutory financial statements including notes to accounts. Prepare cash reports for Senior Management and Group and ensure proper reconciliation is done. Input of banking transactions to various online banking platforms Provide coaching and assistance to junior team members. Revert on queries from internal clients. Provide oversight to ensure correctness and completeness of all finance activities undertaken by the assistant account s officers. Liaise and provide information to Senior Management and Group, including preparation of ad-hoc reports. Establish and maintain effective working relationships with colleagues and other business stakeholders. Liaise with key stakeholders, including internal, external auditors, banks, and government agencies. Provide support to Finance Manager and Team Lead for month end closing activities. Provide support to Finance Manager and Team Lead as and when required. Ensure that current financial and accounting policies, systems, and procedures operate effectively. Qualifications Degree Holder in Finance / Management / Accounting / Economics or Sem-Qualified ACCA Level 2/CA Inter (or experience I lieu) Minimum 4years of relevant experience. Additional information At IQ-EQ we want you to reach your full potential. We offer an inclusive and diverse environment to support your career aspirations. With a strong emphasis on continuous learning and a holistic approach to your professional and personal development. We also offer opportunities across our service lines and our international network of offices. Company description IQ-EQ is a leading Investor Services group which combines global expertise with an unwavering focus on client service delivery. We support fund managers, global companies, family offices and private clients operating worldwide. Qualification : Degree Holder in Finance / Management / Accounting / Economics or Sem-Qualified ACCA Level 2/CA Inter (or experience I lieu)
Iim - Assistant Manager
Machint Solutions
IIM - Assistant Manager Experience: 0 - 1+ Year Location: Hyderabad Job Summary: The Assistant Manager- IIT will support the management team in overseeing daily operations and ensuring the efficient functioning of the department. The role requires strong leadership skills, excellent communication abilities, and the capability to manage and mentor team members. Key Responsibilities: Assist in the planning, coordination, and supervision of daily activities within the department. Manage and monitor staff performance, providing guidance and support to ensure high levels of productivity and morale. Ensure compliance with company policies and procedures, as well as industry regulations. Develop and implement strategies to improve operational efficiency and effectiveness. Handle customer inquiries and complaints, ensuring timely and satisfactory resolution. Prepare and analyze reports on departmental performance, identifying areas for improvement and implementing corrective actions. Collaborate with other departments to ensure seamless integration of operations. Assist in budget preparation and management, ensuring cost-effective use of resources. Participate in recruitment, training, and development of staff. Stay updated on industry trends and best practices to ensure the department remains competitive and innovative. Employee Benefits: 5 day working Free Lunch and Snacks Festivals, family day and team outing Health insurance Flexi working environment Company Sponsored certifications Travel opportunities Bonuses- Fixed, variable, project linked, referral etc. Disclaimer: Machint is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Machint is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.machint.com and Follow us on Twitter, Facebook, LinkedIn, and YouTube.
AI/ML Developer
Infor
Position: AI/ML Developer Company: Infor Location: Hyderabad, India Experience: 2-5 years Skills: AI/ML, Python, AWS, SQL Role Summary: As an AI/ML Developer at Infor, you will be at the forefront of creating and delivering state-of-the-art enterprise applications and automation solutions powered by Infor s AI, RPA, and OS platform technologies. Your primary mission will be to identify impactful AI/ML use cases, develop proof of concepts (PoCs), and deliver automation solutions that drive workforce productivity and enhance business outcomes for our clients. Key Responsibilities: Use Case Identification: Work closely with customers to understand their business challenges and identify opportunities for AI/ML solutions to address these needs. Data Insights: Perform exploratory data analysis on large, complex datasets to uncover key insights. Assess data quality and share findings that can inform decision-making. Data Preparation: Collect, clean, preprocess, and augment datasets for training and testing AI models, ensuring they are ready for AI tasks. Model Development: Design, train, and fine-tune AI/ML models, evaluating them against appropriate performance metrics and optimizing for maximum efficiency. Integration & Deployment: Partner with software engineers to integrate AI/ML models seamlessly into enterprise applications and systems. Address deployment challenges to ensure smooth production workflows. Continuous Improvement: Monitor the performance of deployed AI models, gather user feedback, and iterate to improve models, algorithms, and user experience. Proof of Concepts (PoCs): Develop PoCs to demonstrate the feasibility and effectiveness of AI/ML solutions, showcasing the potential of new technologies to clients. Collaboration: Work closely with development teams to explore and implement new use cases for AI and automation. Best Practices: Collaborate with your team to establish best practices and ensure high-quality development standards. Innovation: Contribute to the innovation of cloud-based enterprise automation solutions and the development of cutting-edge AI technologies. Key Requirements: Experience: Minimum 3 years of hands-on experience in implementing AI/ML models in enterprise environments. AI/ML Knowledge: Strong understanding of supervised and unsupervised learning, reinforcement learning, deep learning, and probabilistic models. Programming Skills: Proficiency in Python or R, with experience in SQL for querying databases. Data Handling: Expertise in working with large datasets, performing data preprocessing, and effectively managing data pipelines. Cloud Infrastructure: Experience with AWS Sagemaker or Azure ML is preferred for deploying machine learning solutions. Frameworks & Libraries: Familiarity with machine learning libraries like scikit-learn, Keras, TensorFlow, PyTorch, or NLTK is a plus. Analytical Skills: Strong critical thinking and problem-solving abilities, with the capacity to design and run experiments to validate hypotheses. Business Process Understanding: Knowledge of business processes and how they can be automated through AI and ML. Domain Expertise: Experience or interest in areas like Demand Forecasting, Anomaly Detection, Pricing, Recommendations, or Analytics. Global Experience: Proven experience in working with global customers on diverse projects, understanding their needs, and delivering tailored solutions. Communication Skills: Excellent verbal and written communication skills, with the ability to clearly explain complex AI concepts to clients and team members. Collaboration & Independence: Ability to work both independently and as part of a team, collaborating with cross-functional teams to drive success. Educational Background: A Bachelor's or Master's degree in Computer Science, Mathematics, Statistics, or a related field. Specialization: Coursework or expertise in AI, ML, Deep Learning, NLP/NLU, Computer Vision, or similar domains is highly desirable.
Avp - Hbeu Reporting Operations
Hsbc
If you re looking for a career where you can make a real impression, join HSBC and discover how valued you ll be. HSBC is one of the largest banking and financial services organisations in the world, with operations in 62 countries and territories. We aim to be where the growth is, enabling businesses to thrive and economies to prosper, and, ultimately, helping people to fulfil their hopes and realise their ambitions. We are currently seeking an experienced professional to join our team in the role of Assistant Vice President HBEU Reporting Operations Principal responsibilities Ensuring consistency among various reporting deliverables in integrated reporting including but not limited to financial statement, capital adequacy & liquidity coverage. Manage Delivery of high quality regulatory outputs including regulatory returns, disclosures and internal MI Presenting to the stakeholders and seeking sign off s before regulatory submission or submission for group. Support the production of existing and designing new integrated reporting information requirements and disclosures (ensuring best practice and compliance with listing requirements and regulatory standards). Proficiency in handling the audit & review queries from internal audit, external audit & regulators supervisory controls (S166). Ensuring that all assurance checks are performed ahead of finalization of numbers and preparation of assurance packs for sign off meetings including variance analysis and review of controls checklist. To be well versed with regulatory interpretation & definition prescribed in various regulation including ECB guidelines, PRA regulation, Applied policies & accounting standards. In-depth knowledge of at least two verticals in either of Financial reporting / Regulatory Reporting / Liquidity reporting. Work with Finance Change delivery, Global Regulatory policy and Remediation programs on upcoming Regulatory changes, business requirements and system enhancements to ensure the solutions delivered are fit for purpose and meets the desired objectives. Active participation in User Acceptance Testing (UAT) for every change/release to drive consistency and efficiency and also highlighting the issues and taking it for remediation. Requirements A qualified professional (preferably CA or ICWA or MBA or CFA) with overall post qualification experience of 8+ years. Sound knowledge of the Financial/Banking Services industry, products and systems. Sound understanding of IFRS, experience in analysis of financial statements, IFRS and audit/compliance Ability to work under pressure, report under tight deadlines and deal effectively with issues as they arise. Prior experience in Regulatory Reporting, Liquidity or Financial Reporting function will be an advantage. Preferably having knowledge and experience in Basel III/CRDIV and PRA regulatory rules; AOP & Stress Testing reporting. The role holder will also continually reassess the operational risks associated with the role and inherent in the business, taking account of changing economic or market conditions, legal and regulatory requirements, operating procedures and practices, management restructurings, and the impact of new technology. Knowledge of Python, R, Xceptor or any upcoming technology used within Finance for automation would be preferred. Qualification : A qualified professional (preferably CA or ICWA or MBA or CFA) with overall post qualification experience of 8+ years.
Sr. Ecompliance Specialist
Novartis
Summary The Senior eCompliance Specialist is responsible for providing Quality Assurance oversight and guidance with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis Quality Manual and global procedures. Sr. eCompliance Specialist provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations, etc.. Provides the guidance to the project and operations team on the CSV related topics and related information. Reviews and/or approves the global Computerized Systems key validation deliverables as a part of the eCompliance support to the GxP projects About the Role Key Responsibilities: • Quality oversight of Project and operational activities of GxP systems (e.g.: changes, Periodic Reviews, deviations, etc.) Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects. • Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture. • Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems. • Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support. • Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented. • Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions. • Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System. • Perform supplier qualification assessment activities • Provides audit support as assigned and in case of CAPAs, provides the required Quality support Essential Requirements: • GXP relevant computerized systems are developed, implemented and maintained according to the Novartis requirements. • On time review and approval of changes, deviations & periodic review reports for the GxP computerized systems. • Documentation supporting eCompliance and CSV requirements is in place, maintained up-to-date and can be presented during audits and inspections without delays and issues • Gaps in eCompliance and CSV activities are proactively identified, escalated and the development of mitigation plans supported. • Client/stakeholder satisfaction and corresponding feedback Desirable Requirements: • 5-10 years of overall experience, and a minimum 4 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and Compliance • Good understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.) • Good experience in the development, implementation and lifecycle management of computerized systems in regulated environments • Experienced in the operational management of GxP solutions including its related technologies to support the operation • Experience in GxP supplier qualification activities • Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.) • Experienced in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space • Successful cross-divisional/functional work with complex international teams • Ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude • Ability to effectively interact and present to Management • Ability to influence without hierarchical authority and build trusted partnerships • Self-starter with experience in initiating and delivering projects and processes • Excellent communication, negotiation, facilitation, and interpersonal skills Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Engineer- .net Developer
Qualcomm
General Summary: The QSWAT group at Qualcomm is seeking full-time engineers to design, develop, and maintain cutting-edge applications utilized by Qualcomm's software development and testing teams. This role involves full-stack web development, scripting, and working with advanced cloud and containerization technologies. Key Responsibilities: Tool Development: Design, develop, and test web-based applications and tools (ASP.NET MVC). Incorporate scripting components (Python, Bash, Perl) as needed. Web Development: Perform full-stack development using modern frameworks and technologies. Work on both client-side (JavaScript/TypeScript, Angular, CSS) and server-side components. Database Management: Utilize SQL Server (2012/2014 or related) and ORM frameworks such as Entity Framework or Dapper. Continuous Integration & Configuration Management: Contribute to CI/CD pipeline development and configuration management processes. Cloud & Containerization (Preferred): Work with cloud technologies such as AWS or Azure. Utilize containerization tools like Docker and Kubernetes. Version Control Systems: Manage code repositories with Perforce or Gerrit. Minimum Qualifications: Education: Required: Bachelor s degree in Computer Engineering, Computer Science, or Information Technology. Experience: Academic or industry experience in the following: Languages & Frameworks: C#, PHP, .NET, ASP.NET MVC, Python, Perl, Bash. Web Technologies: JavaScript, TypeScript, Angular, CSS. Databases: SQL Server, Entity Framework, Dapper. Version Control: Perforce, Gerrit. Cloud & Containers (Preferred): AWS, Azure, Docker, Kubernetes. Knowledge in CI/CD pipelines, build infrastructure, and tools development. Work Environment & Accessibility: Qualcomm is committed to creating an accessible hiring process for individuals with disabilities. Equal Opportunity Employer: Qualcomm embraces diversity and prohibits discrimination based on race, gender, disability, and other protected categories. This role offers an exciting opportunity to work at the forefront of software automation and tool development. If you need help with application tips, resume optimization, or preparation for interviews, feel free to ask! Qualification : Bachelors degree in Computer Engineering, Computer Science, or Information Technology.
Branch Accountant
Nspira Management Services
About Us: Nspira, a part of the renowned Narayana Group, is one of Asia's largest educational conglomerates, providing world-class education to over 6,00,000 students. With 50,000+ faculty members and 600+ institutions across India, we are at the forefront of shaping the future of education. Our success is built on a strong foundation of excellence, innovation, and a commitment to meeting the aspirations of India s students. Roles & Responsibilities: Maintain books of accounts in compliance with accounting norms and standards. Verify and process vendor bills and other payments in a timely manner. Manage petty cash balances and ensure accuracy in financial transactions. Handle accounts related to student applications, ensuring proper documentation and processing. Prepare payroll, expense sheets, and generate timely reports for management review. Assist in the preparation of financial statements and statutory compliance documentation. Ensure all statutory compliances are met, including tax filings and other legal requirements. Support senior management in financial reporting and budgeting. Provide hands-on assistance with financial tasks as needed, utilizing MS Office tools. Eligibility & Requirements: Education: B.Com, M.Com, or MBA in Finance (mandatory). Experience: Freshers or candidates with relevant experience in Accounts/Finance are welcome to apply. Skills: Strong subject/domain knowledge in Accounts and Finance. Hands-on experience using MS Office (Excel, Word, etc.). Knowledge of statutory compliance and regulations. Detail-oriented with the ability to manage multiple financial tasks simultaneously. Good communication skills and the ability to work collaboratively. What We Offer: Salary: Competitive salary based on market standards. Career Growth: Progressive career path with opportunities for professional development. Exposure: Corporate exposure in one of the largest educational organizations in Asia. Personality Development: Continuous learning and growth opportunities. Leadership Opportunities: Chance to take on leadership roles and make an impact. What You Can Bring: Passion for the role and a drive to excel in financial management. Strong multitasking ability to handle various accounting tasks efficiently. A good team player with excellent communication skills. A positive, proactive attitude with a desire to learn and grow. A commitment to integrity, sincerity, and transparency in all work. Employee Progression: At Nspira, we provide ample opportunities for staff to grow within the organization. Many of our employees have been with us for 20-30 years, advancing in their careers across different roles and capacities. If you have the skills and passion for financial management and are ready to be part of a dynamic team, we would love to hear from you!
Assistant Manager- Finance & Accounts
Nephroplus
Job Description: Nephroplus is looking for aspiring candidates who will be responsible for planning, designing, developing, and evaluating computer systems. MIS Executives have various duties depending on the type and size of the organization they work for. Result oriented, willing to travel and demonstrate outstanding guest centric behaviour. Must be a team player with effective communication skills to deal with team members and all levels within the organization. Roles & Responsibilities: Preparing and leading the KPI reporting daily, weekly, and monthly reports Preparation of Doctors Payouts across various centers on monthly basis. Maintain Trackers for individual Center wise & Monthly reports Knowledge in Preparing & managing multiple reports on requirement from other teammates in the company. Knowledge in Preparing & managing multiple reports on requirement from other teammates in the company. Good typing speed Hands on experience in excel functions i.e. V-LOOKUP, PIVOT TABLE, IF and other functions. Coordinate daily with all stakeholders and follow-up A team player who is always willing to extend his support towards the team & the organization A team player who is always willing to extend his support towards the team & the organization Self-motivated and quick leaner Job Specification: Bachelor's degree in Computer Science, IT, or similar. Practical experience with a variety of software applications. Attention to detail. Outstanding written and verbal communication. Willingness to continually self-educate Behavioural Competencies: Empathy & Flexibility Ethical in thought and action Ability to work with diverse teams, able to influence and build professional relationships Accountability and Responsibility Intrinsically motivated for the job Qualification : Bachelor's degree in Computer Science, IT, or similar.
Senior Financial Analyst Compliance And Audit
Techolution
Department: Account Payable Techolution is seeking an experienced Senior Financial Analyst Compliance and Audit to join our team. In this role, you will be responsible for all aspects of financial management, including corporate accounting, regulatory and financial reporting, budget and forecasts preparation, as well as the development of internal control policies and procedures. You will also support Audits and compliances for India, US, Singapore, and Indonesia. The ideal candidate should be hands-on, willing to jump in wherever necessary, and possess a careful, hardworking, and diligent approach to multitasking and staying on top of the entire checklist of things. Audit experience is mandatory for this position. Location: Hybrid (Hyderabad) Work Timings: (2 PM to 11 PM) 1. Prepare and review all the Compliances with the help of consultants in US & India. 2. Analyzing the Notices received and addressing them with the help of consultants for all countries and submit risk finding report to the senior management. 3. Submit all transaction documents, resolve queries and liaise with tax consultants to ensure tax compliance for all Countries. 4. Administer all direct tax and Indirect Tax processes/notices and compliance, including GST, TDS, corporate tax, transfer pricing, tax audit, payroll taxes etc. 5. Liaisoning with the tax consultant and auditors with respect to the submissions, Stat Audits, assessment and appeal hearings before tax authorities in connection with the above. 6. Preparation and analysis of Monthly/Quarterly/yearly financial statements as per GAAP. 7. Hands on experience in finalization of accounts. 8. Assist in planning and executing external review and audits. 9. Gather and prepare documentation required for audits, including financial statements, transaction records, and compliance reports. 10. Collaborate with auditors to address queries and provide necessary information. 11. Review audit findings and work with management to develop and implement corrective actions. 12. Identifying financial performance trends and financial risk, and making recommendations. 13. Providing the audit support documents. 14. Exposure in addressing in audit questions. 15. Understanding key business drivers and preparation of various MIS reports. 16. Developing financial projections and building financial models. 17. GST scrutiny of books. About Techolution At Techolution, we specialize in building custom AI solutions that deliver innovation and drive measurable outcomes for enterprises worldwide. With our specialized expertise we help businesses take AI from their labs into the real world.
Support And Data Analyst/ Senior Business Analyst
Hsbc
Job description Some careers shine brighter than others. If you re looking for a career that will help you stand out, join HSBC, and fulfil your potential. Whether you want a career that could take you to the top, or simply take you in an exciting new direction, HSBC offers opportunities, support and rewards that will take you further. HSBC is one of the largest banking and financial services organizations in the world, with operations in 64 countries and territories. We aim to be where the growth is, enabling businesses to thrive and economies to prosper, and, ultimately, helping people to fulfil their hopes and realize their ambitions. We are currently seeking an experienced professional to join our team in the role of Senior Business Analyst In this role you will: Protect: To protect our data we need robust policies for data management and enhanced governance e.g. data that is consumed from a trusted source, meets quality standards, and complies with regulatory obligations. Connect: Move to a data-led culture through enhanced training including on the job opportunities. Our talent is the glue between protecting our data and unlocking value for our customers. Unlock. Value is unlocked when we deliver on the opportunities our well-managed data presents e.g. improving customer / colleague experience, increasing revenue, commercialising our data, optimising capital, enhancing risk management or reducing costs. Key Responsibilities: Supporting our DataVisa and ROP communities Access management configuration Issue triage Issue investigation and troubleshooting Data analysis and report preparation for customers and leadership teams. Requirements To be successful in this role you should meet the following requirements: Minimum work experience of 6 to 8 years Minimum bachelor s degree Manage and support the analysing and documenting of technical issues arising in DataVisa and Manage ROP Manage and support the investigations into technical issues Support the change management activities which can include diverse tasks such as timeline planning to stakeholder engagement Identify impact of change on training materials and communication channels Manage and support the tracking and documenting progress and managing status reporting Assisting in the implementation of solutions. Qualification : Minimum bachelors degree
Manager, Regulatory Affairs - CMC
Msd
Job Opening: Manager, Regulatory Affairs - CMC Location: Hyderabad, India | Full-Time About the Role The Manager, Regulatory Affairs - CMC, is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products, in accordance with global regulations and defined regulatory strategies. This role will involve preparing and reviewing the necessary information for the development of regulatory CMC dossiers for commercial products. Our Regulatory Affairs team is dedicated to advancing medical breakthroughs by facilitating communication and procedures that ensure swift, organized compliance across regulatory agencies. As part of our international network, you will play an integral role in ensuring the compliance and approval of medical products, helping to provide reliable healthcare solutions to the world. Primary Responsibilities Regulatory Responsibilities: Provide input to global product and project regulatory strategies by assessing CMC changes and identifying global regulatory requirements. Lead the development, authoring, and review of CMC submission components and documentation to support post-approval supplements, variations, annual reports, registration renewals, and responses to health authority questions. Liaise with global CMC, Manufacturing Divisions, and external partners to ensure compliant execution of change management. Assess and communicate potential regulatory risks and propose mitigation strategies. Ensure timely delivery of all regulatory milestones for assigned products across the product lifecycle. Identify and communicate potential regulatory issues to GRACS CMC management as needed. Technical Skills: Review scientific information to assess the technical merits and suitability of scientific rationale, ensuring clarity and support from data. Demonstrated ability to communicate issues succinctly and logically, both orally and in writing. Solid understanding of related fields such as pharmaceutical manufacturing, analytical testing, and quality assurance. Proficient in operating electronic document-based GMP systems. Leadership Skills: Ability to generate innovative solutions to problems and effectively communicate with key stakeholders. Demonstrated flexibility in adapting to changing priorities and dealing with unexpected events. Capability to handle multiple priorities and balance work to achieve business goals. Effective leadership, communication, and interpersonal skills. Qualifications & Skills Bachelor's degree in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry. Minimum of 5-7 years of experience in the pharmaceutical industry, with at least 4 years of experience in managing CMC regulatory submissions for small molecules, vaccines, or biologics. Ability to travel to other CMO sites on a need basis. Join a global company that is leading the charge in medical advancements. Play a vital role in ensuring compliance and regulatory success for life-changing pharmaceutical products. Collaborate with diverse teams to drive innovation and shape the future of healthcare. We are proud to be a company that embraces diversity and fosters an inclusive environment. At our organization, the fastest breakthroughs come when diverse ideas come together. We encourage our colleagues to challenge each other s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to promoting diversity and inclusion in the workplace. What We Look For If you re passionate about regulatory affairs and ready to make a meaningful contribution to the global pharmaceutical landscape, join us. Your expertise will help shape the future of medicine and impact generations to come. Qualification : Bachelor's degree in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
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