Associate Manager - MSAT (C&Q)
Pfizer · Vizag, India
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Role summary
Associate Manager role at Pfizer's Vizag facility focused on validation, compliance, and quality assurance in sterile pharmaceutical manufacturing. Requires 6-8 years of experience in validation, quality assurance, or injectable production with expertise in GMP, equipment qualification, and regulatory compliance.
What they're looking for
- B. Pharm, M. Pharm, B.Tech, or BE degree
- 6-8 years in quality assurance, validation, or sterile dosage form manufacturing
- Strong knowledge of GMP, validation principles, and pharmaceutical manufacturing operations
- Expertise in equipment qualification (autoclaves, filling machines, depyrogenation) and CSV systems
- Proficiency with IQ/OQ/PQ protocols and validation documentation; familiarity with GAMP, PDA guidance, 21 CFR Part 11
- Experience in root cause analysis, problem-solving tools (DMAIC), and regulatory audit support
- Excellent written and verbal communication; working knowledge of quality systems and information platforms (GDMS, SAP, QTS)
What you'll be doing
- Evaluate, review, and approve validation master plans, protocols, and reports for regulatory compliance
- Troubleshoot and resolve validation issues for equipment and manufacturing processes
- Conduct statistical analysis of test results and provide data analysis support for quality investigations
- Guide development and review of validation documents and technical reports adhering to Pfizer standards
- Manage quality systems including change control, quality agreements, and investigations; coordinate testing across teams
Privacy & handoff
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