Job Overview
Pfizer is seeking an Associate Manager of Quality Assurance in Chennai, India. The role involves ensuring compliance with regulatory requirements, reviewing analytical and development data, and supporting sterile product development. This position is ideal for candidates with strong knowledge of cGMP, data integrity, and sterile product regulations, along with experience in analytical data review and technology transfer.
Job Details
Company: Pfizer
Job Position: Associate Manager Quality Assurance
Location: Chennai, India
Qualification: Master of Science in Chemistry or Master of Pharmacy
Salary: Estimated ₹12–18 LPA (based on industry standards and experience)
Key Responsibilities
- Review documents related to product development and analytical data.
- Ensure compliance with data integrity standards during hard copy and electronic reviews.
- Conduct system audit trail reviews per 21 CFR Part 11.
- Collaborate with global BL and OQ colleagues for organizational objectives.
- Maintain understanding of ICH quality guidelines and regulatory guidance.
- Support sterility, BET, CCIT, and microbiology method development.
- Review sterility requirements and filter validation per PDA technical reports.
- Apply sterile ANDA product development and combination product requirements.
- Review instrument and equipment qualification documentation.
- Participate in inspection readiness activities and audits.
- Evaluate statistical data during method development and validation reviews.
- Assist in implementing new initiatives within QA functions.
- Ensure laboratories maintain compliance with cGMP standards.
- Suggest improvements and contribute to continuous improvement projects.
- Provide quality support across business partner procedures and regulatory inspections.
Required Skills and Knowledge
- Strong understanding of Data Integrity (DI) and ALCOA principles.
- Knowledge of cGMP requirements (21 CFR Part 210 & 211).
- Experience in sterile product quality assurance.
- Proficiency in reviewing analytical data and chromatographic audit trails.
- Ability to manage document reviews effectively.
- Familiarity with ICH guidelines and regulatory standards.
- Knowledge of sterility and microbiology development requirements.
- Experience in technology transfer processes.
- Proficiency in statistical data evaluation.
- Strong understanding of sterile manufacturing practices.
- Skilled in inspection readiness and audit participation.
- Effective communication and collaboration skills.
- Self-motivated with strong discipline.
- Skilled in MS Office (Excel, Word, PowerPoint).
- Ability to plan and manage QA activities within project timelines.
About Pfizer
Pfizer is a global biopharmaceutical leader committed to developing innovative therapies that improve healthcare outcomes and transform lives. With a focus on scientific excellence, regulatory compliance, and continuous improvement, Pfizer offers a collaborative culture where every individual can contribute to advancing healthcare worldwide.
Why Join Pfizer
- Work with one of the world’s leading pharmaceutical companies.
- Contribute to life-changing healthcare innovations.
- Be part of a diverse and inclusive global workforce.
- Access to advanced research and development facilities.
- Strong emphasis on compliance and quality standards.
- Opportunities for professional growth and development.
- Involvement in global regulatory and quality operations.
- Exposure to cutting-edge sterile manufacturing processes.
- Continuous learning through training and knowledge-sharing programs.
- Opportunity to collaborate with global quality teams.
- Culture that values ownership, innovation, and teamwork.
- Access to modern digital and analytical tools.
- Strong support for employee well-being.
- Encouragement for new initiatives and process improvements.
- Long-term career stability with competitive compensation.
Important Links
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