FDA Jobs in Hyderabad

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

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.

We are seeking a dynamic Consultant to lead our team in implementing SAPIO Sciences LIMS and ELN solutions for our clients. This position entails designing solutions and configuring SAPIO Sciences systems to align with client requirements in lab informatics. The ideal candidate will bring a wealth of technical expertise and leadership skills to successfully deliver SAPIO LIMS and ELN projects. Responsibilities Lead SAPIO Sciences LIMS and ELN project implementations Customize and script SAPIO functionalities using Python, JavaScript, and SQL Manage integration of systems using RESTful APIs, Webhook, and web services Utilize port forwarding tools such as ngrok or Cloudflare to facilitate effective system communications Oversee database management for projects, specifically with PostgreSQL or similar technologies Implement cloud deployment strategies for SAPIO solutions using AWS, Azure, or GCP Configure and maintain Gunicorn application servers and ensure smooth operation of Flask/Django frameworks for web applications Set up and manage Nginx reverse proxy servers to optimize system performance Understand and implement lab workflows, sample accessioning, and efficient lab data management practices Ensure compliance with industry standards like GxP, FDA 21 CFR Part 11 in regulated environments Requirements 6 to 12 years of experience in Lab Informatics or related fields Strong technical expertise in SAPIO Sciences LIMS and ELN implementations Background in programming with proficiency in Python, JavaScript, and SQL Extensive experience with databases, focusing on PostgreSQL or equivalent Proficiency in cloud technologies including AWS, Azure, and GCP Excellent capability in managing API integrations and utilizing port forwarding tools Strong knowledge of reverse proxy servers (Nginx) and Python web application servers (Gunicorn) Competency in understanding and managing lab workflows and data management processes Background in working within regulated industries like Pharma, Biotech, etc Nice to have Knowledge of other LIMS/ELN platforms (LabWare, LabVantage) Certification in SAPIO Sciences or related tools Familiarity with laboratory instrument integration We offer Opportunity to work on technical challenges that may impact across geographies Vast opportunities for self-development: online university, knowledge sharing opportunities globally, learning opportunities through external certifications Opportunity to share your ideas on international platforms Sponsored Tech Talks & Hackathons Unlimited access to LinkedIn learning solutions Possibility to relocate to any EPAM office for short and long-term projects Focused individual development Benefit package: Health benefits Retirement benefits Paid time off Flexible benefits Forums to explore beyond work passion (CSR, photography, painting, sports, etc.) Qualification : 6 to 12 years of experience in Lab Informatics or related fields

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.