Facility Inspection Jobs in Hyderabad

Company: Evergent About Evergent: Evergent is a leading technology provider that works behind the scenes to impact the lives of millions of consumers across the world, every single day. Having onboarded over 800 million subscribers for our clients, Evergent is trusted by the likes of SonyLIV, HBO, the NBA, AT&T and BBC to power the subscriber journeys and experience for their subscribers across more than 180 countries. This has been made possible due to our secret sauce - our people. With an approach of bringing together the best of Silicon Valley and the best of India, our team of 500+ Evergenters have delivered world-class technology products and have driven industry-leading transformation projects for our clients. Our solutions help our clients innovate with new revenue streams, increase subscriber loyalty, and control churn - without requiring an overhaul of their legacy billing and payment systems. Our true multi-tenant SaaS approach means that our clients can go live in weeks, and not months or years. At the same time, our carrier-grade infrastructure assures our clients of an unparalleled ability to scale across the globe. As we continue on our journey of creating a positive impact for businesses and consumers - we would love for you to come and meet with us. Job Title: Facilities Admin Executive Experience: 3+ Years Location: Hyderabad Job Summary: The Facilities Admin Executive will oversee and manage the day-to-day operations of office facilities, ensuring a safe, clean, and efficient work environment. This role requires strong organizational skills, attention to detail, and the ability to manage multiple tasks simultaneously. The ideal candidate will have experience in facility management, vendor coordination, and administrative support. Key Responsibilities: Vendor Management: Oversee the maintenance, repair, and upkeep of the office premises, including HVAC, plumbing, electrical, Fire Alarm System and general office maintenance. Maintaining the inventory for housekeeping material, office supplies, stationery, etc. Manage the reception area, including visitors, customers and partners entry formalities and necessary arrangements. Monitoring the daily checklists and activity execution. Required Skills and Qualifications: Bachelor s degree or relative field. 3+ years of experience in facilities management, office administration, or a related role. Strong organizational and multitasking abilities. Good communication and interpersonal skills. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Work Environment: Office-based role with movement between Evergent office locations as needed. May require flexibility to handle emergencies outside of regular business hours / days. May require flexibility to travel within the city for office related assignments. Qualification : Bachelors degree or relative field.

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

Associate Administration / Front Office Location: Hitec City, Hyderabad, Telangana Experience: Minimum 3 Years Employment Type: Full-time Job Summary We are looking for a dynamic and well-organized Associate Administration / Front Office to oversee front desk operations and support administrative functions. The ideal candidate should have a strong ability to multitask, communicate effectively, and ensure smooth day-to-day operations within a corporate office environment. Key Responsibilities Manage front office and general administrative operations to ensure a well-run and professional environment. Schedule inter-departmental meetings, coordinate with staff for availability, and handle logistics including refreshments and necessary materials. Handle the calendar and travel arrangements for the management team including hotel bookings, meeting room setup, and arranging A/V equipment. Organize and maintain company documentation, internal records, and files. Handle confidential and sensitive information with professionalism and discretion. Assist with office budget planning and track expenditures and vendor payments. Support HR and Admin teams with organizing training programs, team events, and onboarding/offboarding activities. Coordinate daily housekeeping and maintenance tasks; liaise with facility and external service vendors for smooth office operations. Provide administrative assistance to various department heads and ensure their operational needs are met. Prepare reports and presentations, maintain office inventory, and support audit and compliance documentation. Requirements Educational Qualification: Bachelor s degree in Commerce, Arts, or related field. Experience: Minimum 3 years in a front office or administrative role. Skills: Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) is mandatory. Excellent verbal and written communication. Strong organizational, coordination, and time-management skills. Positive attitude, professional demeanor, and ability to multitask. Prior experience handling confidential and executive-level support will be a plus. Preferred Attributes Exposure to corporate front desk/administrative support in a tech or enterprise environment. Quick-thinking and ability to independently resolve day-to-day office issues. Well-versed in coordinating with vendors, staff, and third-party services. Qualification : Bachelors degree in Commerce, Arts, or related field.

Business Development Representative (BMS) Location: Hyderabad Company: Smart Joules Employment Type: Full-time About Smart Joules Smart Joules is a leading provider of energy efficiency solutions, transforming the way commercial buildings consume energy. Our cutting-edge Building Management Systems (BMS) use real-time analytics and smart automation to deliver measurable cost savings and carbon footprint reductions. We are on a mission to create a sustainable future by empowering organizations to manage energy smarter. Role Overview We re looking for a dynamic Business Development Representative to drive the growth of our BMS solutions across commercial sectors. If you have a passion for sustainability, a knack for consultative selling, and a deep understanding of energy management technologies, we d love to have you on board. Key Responsibilities Identify & Prospect: Research and engage with commercial sector clients who can benefit from Smart Joules BMS offerings. Sales Engagement: Conduct product demonstrations, presentations, and client meetings to effectively communicate value propositions. Consultative Selling: Collaborate with technical teams to design customized BMS solutions tailored to client needs. Pipeline Management: Maintain an organized sales pipeline, follow up diligently, and close deals to meet revenue targets. Client Relationship Management: Build long-term relationships with key decision-makers and stakeholders. Reporting & Insights: Prepare proposals, sales reports, and provide feedback for continuous product and strategy improvement. Requirements Bachelor's degree in Business, Engineering, or a related field. Proven experience in B2B sales, ideally within building management systems, energy management, or sustainability solutions. Strong technical understanding of BMS, HVAC, and energy-saving technologies. Excellent communication, negotiation, and presentation skills. Self-motivated, target-driven, and able to work independently or collaboratively. Willingness to travel as needed. Preferred Qualifications Prior experience in energy efficiency or sustainability sectors. Existing network within the commercial real estate, healthcare, retail, or hospitality industries. Familiarity with CRM tools (e.g., Salesforce, Zoho CRM). Contribute to impactful work that drives sustainability and reduces carbon emissions. Work in a collaborative and mission-driven environment. Opportunities for career growth, training, and professional development. Be part of a team that s revolutionizing how buildings think and operate. Apply today and help shape a greener, smarter tomorrow. Qualification : Bachelor's degree in Business, Engineering, or a related field.

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.

Join Amgen s Mission of Serving Patients At Amgen, you ll be part of something bigger driven by our shared mission to serve patients with serious illnesses. Since 1980, we ve been pioneering biotech innovations, focusing on oncology, inflammation, general medicine, and rare disease.Join us to help make a lasting impact on patients lives while transforming your career. Case Management QA Vendor Associate What You Will Do: As a Case Management QA Vendor Associate, you will play a vital role in ensuring the quality and compliance of global case intake and processing activities. You will oversee vendors, manage case quality, and ensure adherence to regulatory requirements while supporting inspections, audits, and continuous improvement initiatives. Key Responsibilities: Monitor and ensure vendors deliver high-quality Individual Case Safety Reports (ICSRs) that meet global regulatory standards. Act as the US/EU local safety office and primary FDA/EMA point of contact for safety reporting. Provide training and resources to vendors to maintain compliance and quality. Perform quality control reviews, trend analysis, and generate reports on case quality. Manage vendor case processing timelines for adverse event intake, triage, and submission. Support inspections, audits, and CAPA (Corrective and Preventive Action) activities. Assist in Periodic Aggregate Safety Reports (PASR) processes and maintain a state of inspection readiness. Collaborate with local safety offices and attend vendor management meetings. Analyze QC trends and recommend improvements. Support onboarding and offboarding of vendor staff. What We Expect of You Basic Qualifications: Bachelor s degree with 3 years of related experience, or Associate s degree with 5 years of related experience, or High school diploma/GED with 7 years of related experience Previous experience in managing teams, projects, or resource allocation Preferred Skills: Knowledge of global pharmacovigilance regulatory requirements Proficiency in safety case processing and experience with global safety databases Strong communication skills, attention to detail, and experience supporting audits/inspections Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook What You Can Expect from Us Amgen is committed to supporting your professional growth and well-being with a collaborative, science-driven culture and a competitive Total Rewards Plan aligned with industry standards. Equal Opportunity Amgen is an Equal Opportunity Employer and embraces diversity. We provide reasonable accommodations for individuals with disabilities throughout the application process.

Job Description: Safety Officer Experience: 2+ Years Qualification: Diploma in Construction Safety, Diploma in Health & Safety Job Description: We are looking for a Safety Officer to ensure the safety and health of all personnel on site and in our workplace. The ideal candidate should have a minimum of 2 years of experience in safety management, specifically in construction or industrial environments, and be well-versed in safety standards and practices. Key Responsibilities: Toolbox Talks & Safety Training: Prepare and deliver Toolbox Talks to ensure the team is up-to-date on safety protocols. Organize and arrange safety training classes and workshops for employees, including first aid and fire safety training. Arrange monthly safety bulletin distributions to keep the team informed about the latest safety practices. Accident Reports & Statistics: Prepare monthly safety statistics to track accidents, incidents, and overall safety performance. Draft and maintain accident reports and analyze root causes to improve future safety measures. Safety Inspections & Equipment Checks: Conduct regular inspections of workplace safety equipment, such as fire extinguishers, and ensure they meet safety standards. Conduct routine safety inspections and ensure all safety regulations and compliance requirements are followed. Safety Competitions & Awareness Programs: Organize safety competitions such as quizzes, slogan competitions, and poster exhibitions to increase awareness and engagement among employees. Safety Documentation & Reporting: Maintain and update safety checklists to ensure compliance with all required safety procedures. Participate in management meetings to discuss safety performance, risks, and improvement strategies. Other Duties: Provide suggestions and improvements on health and safety measures in the workplace. Collaborate with various departments to ensure a safe working environment and compliance with health and safety regulations. Qualifications and Skills: Experience: Minimum 2 years of experience in safety management in construction or similar environments. Certifications: Diploma in Construction Safety and Diploma in Health & Safety are mandatory. Technical Skills: Ability to prepare and deliver toolbox talks and safety training programs. Skilled in preparing accident reports, safety statistics, and checklists. Strong knowledge of safety regulations and procedures in construction or industrial environments. Communication: Excellent communication and interpersonal skills to handle safety training, awareness programs, and safety meetings. Additional Skills: Ability to organize safety competitions, such as quizzes and poster competitions, to raise safety awareness among employees. Detail-oriented with strong organizational and planning skills to arrange and track safety activities and training. What We Offer: Competitive salary and benefits. A dynamic and collaborative work environment. Opportunities for professional development and growth in the field of safety management. Qualification : Diploma in Construction Safety and Diploma in Health & Safety are mandatory.

Position: Solution Consultant SAP EAM Location: Hyderabad, Telangana, India Employment Type: Full-Time, Salaried Compensation: Base Salary + Bonus + Benefits About Innovapptive: Innovapptive is transforming the industrial workforce by connecting front-line workers, back-office teams, and assets through the only patented, Code-Free connected worker platform for SAP and IBM Maximo. Our platform digitizes manual, paper-based processes in maintenance, operations, and supply chain with highly configurable mobile apps, giving real-time visibility and actionable insights to back-office teams. Trusted by global leaders like Newmont Mining, Shell, UNICEF, and Reckitt Benckiser, we save companies millions by improving asset uptime, productivity, safety, and workforce efficiency. Backed by Tiger Global Management and recently funded by Vista Equity Partners, Innovapptive is rapidly growing and committed to empowering 350 million industrial front-line workers worldwide. Role Overview: The Solution Consultant will engage directly with plant maintenance leaders to consult on value improvement, maturity assessments, process enhancements, and mobility best practices. You will lead solution design workshops, drive adoption of Innovapptive s cloud-based SaaS connected worker solutions, and support customers in achieving key operational KPIs such as: Efficient plant maintenance execution Timely maintenance work completion Compliance with regulatory and industry standards Key Responsibilities: Collaborate with customers and internal teams to gather and prioritize requirements, translating them into actionable product features. Lead solution design workshops and create value models demonstrating cost savings and operational improvements. Document test scenarios and maintain traceability matrices aligned with business requirements. Promote rapid, agile solution iterations ensuring quality, efficiency, and speed to value. Ensure delivery timelines and quality standards are met, driving ROI and user adoption post-implementation. Partner with product management to influence roadmap and feature prioritization. Analyze user personas to tailor solutions that alleviate core pain points of maintenance professionals. Develop training materials and documentation to empower end-users. Collaborate across engineering, design, marketing, and sales teams to ensure aligned product development. Embrace a startup mindset adaptable, resilient, and entrepreneurial. Qualifications & Experience: Bachelor s degree in Computer Science, IT, or related field. 5+ years as a solution engineer or functional expert in Smart Manufacturing / Connected Plant applications. 3+ years domain experience in Maintenance and Operations. Strong expertise in Plant Maintenance processes: Work Order Planning & Scheduling, Notifications, Execution, Functional Locations, Inspections, and Permits. Experience with full cycle project implementations is preferred. Excellent analytical, problem-solving, organizational, and communication skills. Self-motivated, able to work independently and within teams. Leadership experience and project coordination skills are a plus. Certifications like CCBA or CBAP are desirable. What We Offer: Collaborative, innovative, and entrepreneurial work environment Opportunities to work with global brands on impactful projects Competitive salary and benefits including medical insurance for family Paid maternity and paternity leave Generous vacation and paid time off Bi-annual performance reviews and transparent feedback culture Extensive learning and development resources Active interest groups and clubs (Book Reading, Toastmasters, Sports, Music) Innovapptive is an equal opportunity employer committed to diversity and inclusion. Qualified applicants will receive consideration without regard to protected characteristics under applicable law. Qualification : Bachelors degree in Computer Science, IT, or related field.

Senior Analyst Controllership, Finance Locations: Hyderabad & Bangalore Company: Arcesium Company Overview Arcesium is a global financial technology firm helping the world s most sophisticated financial institutions tackle complex, data-driven challenges. Our innovative platform, built to anticipate risks and power transformational business outcomes, continues to redefine operational excellence in the investment management industry. With a solid market foundation and strong growth trajectory, Arcesium offers an intellectually stimulating environment, where proactive ownership, collaboration, and continuous learning are core to our success. About the Role We are looking for a dynamic and detail-oriented Senior Analyst Controllership, Finance to join our growing Finance team in Hyderabad or Bangalore. This role is ideal for a qualified Chartered Accountant with strong technical acumen in accounting, taxation, regulatory compliance, and financial controls. You will be responsible for ensuring the integrity and accuracy of financial records, maintaining strong internal controls, managing key audits, and ensuring compliance with statutory and regulatory frameworks. Key Responsibilities Financial Accounting & Reporting Drive accuracy and completeness of financial statements and month-end close processes. Ensure compliance with applicable accounting standards, including Ind AS, and corporate governance requirements. Taxation & Compliance Direct Taxation: Manage TDS payments and returns, advance tax, annual income tax filings. Handle income tax assessments and departmental correspondence. Indirect Taxation: Oversee monthly GST filings and payments, annual GST returns, and GST refund applications. Respond to GST notices and regulatory queries. Other Statutory Requirements: Ensure timely filings with ROC, RBI, SEZ, STPI, and compliance with the Companies Act and corporate laws. Maintain accurate documentation for inspections and audits. Internal Controls & Process Improvement Collaborate with internal teams to assess and strengthen internal financial controls. Conduct regular process reviews and feedback sessions to implement improvements. Prepare and maintain SOPs, RCMs, and key dashboard metrics. Stakeholder & Audit Management Serve as the point of contact for all external advisors on tax and compliance matters. Coordinate and support: Statutory audits Internal audits Tax audits IFC audits Other external/regulatory audits Treasury & Payables Oversee accounts payable processes and ensure timely, error-free vendor payments. Manage treasury operations, including cash flow forecasting, banking, and forward contracts. What You ll Need Qualifications & Experience Chartered Accountant (CA) with 4 6 years of post-qualification experience. Strong technical knowledge of: Indian Accounting Standards (Ind AS) Companies Act Direct and Indirect Taxation Skills & Tools Strong analytical mindset and a problem-solving approach. Hands-on experience with Oracle ERP (preferred). Excellent communication and interpersonal skills. A proactive team player with high attention to detail. Be part of a high-performing team tackling some of the most complex financial challenges. Enjoy a culture that values intellectual curiosity, autonomy, and inclusive collaboration. Work with a firm that truly values professional development and diverse perspectives. Equal Opportunity Employer Arcesium is committed to creating an inclusive work environment. We do not discriminate on any basis and encourage candidates from all backgrounds to apply. Qualification : Chartered Accountant (CA) with 46 years of post-qualification experience.

Let s do this. Let s change the world. In this vital role you will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes in tools like Veeva Study Startup. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the GxP applications. Defining the scope, objectives, and approach of the validation process, creating detailed validation plans, and aligning them with project timelines and resources Perform Validation testing, including Installation Qualification (IQ), Operational Qualification (OQ) for new and existing SSU Systems Ensure compliance with industry standards, regulations and internal policies during all validation activities. (GxP, FDA 21 CFR Part 11) Identify, document, and track defects during the testing process. Collaborate with development teams to define validation requirements, resolve defects and validate fixes. Maintain comprehensive audit trails and validation documentation to support regulatory inspections. Configure and optimize workflows within the Veeva Vault Management (VVM) to streamline test management and approval processes. Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements. Act as a liaison between technical teams and stakeholders to ensure system requirements are met. Provide training to end-users on Veeva VM Testing Vault functionalities and best practices. Assist in the development and continuous improvement of validation processes and procedures Stay up to date with industry trends, best practices and evolving regulatory needs We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor s degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 10 to 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Must-Have Skills: Solid understanding of GxP regulations, specifically 21 CFR Part 11. Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc. Experience in defining and executing validation strategies aligned with regulatory requirements Familiarity with risk-based approaches to validation Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) Excellent documentation and report writing skills Good-to-Have Skills: Proficiency in automation tools, data systems, and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodology Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFe for Teams certification (preferred) Veeva VM certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

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.

Key Accountabilities: Project Management: Ability to fill Statistical Programming Lead role on projects Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Review statistical analysis plans and mock-shells. Review database set-up specifications. Interact with sponsors and internal stakeholders with regard to statistical programming issues. Assist project teams in the resolution of problems encountered in the conduct of their daily work. Statistical Programming for Assigned Projects: Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings. Produce/QC dataset specifications and other process supporting documents and submission documentation. Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. Provide relevant training and mentorship to staff and project teams. General: Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in and/or lead process/quality improvement initiatives. Provide consultancy to internal and external sponsors with regard to statistical programming tasks. Represent PAREXEL at sponsor marketing and technical meetings. Understand regulatory requirements concerning industry technical standards(e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: Excellent analytical skills. Proficiency in SAS. Extensive knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Strong project management skills. Strong organizational skills, ability to manage competing priorities, and flexibility to change. Attention to detail. Ability to successfully lead a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Demonstrate commitment to refine quality processes. Good presentation skills. Good business awareness/business development skills (including financial awareness). Knowledge and Experience: Competent in written and oral English. Excellent communication skills. Education: Educated to degree level in a relevant discipline and/or equivalent work experience. Qualification : Educated to degree level in a relevant discipline and/or equivalent work experience.

Key Accountabilities: Project Management: Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Statistical Programming for Assigned Projects: Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. Provide relevant training and mentorship to staff and project teams as appropriate. General: Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in process/quality improvement initiatives. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: Excellent analytical skills. Proficiency in SAS. Knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Ability to manage competing priorities and flexibility to change. Attention to detail. Ability to successfully work as part of a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Knowledge and Experience: Competent in written and oral English. Good communication skills. Education: Educated to degree level in a relevant discipline and/or equivalent work experience. Qualification : Educated to degree level in a relevant discipline and/or equivalent work experience.