Job Title: Associate Manager – MSAT Validation
Location: Visakhapatnam, India
Employment Type: Full-time | On Premise
About the Company:
Pfizer is a global leader in pharmaceuticals, dedicated to breakthroughs that change patients’ lives. Pfizer Global Supply (PGS) manufactures and distributes a wide range of medicines while maintaining the highest safety, quality, and compliance standards.
Role Overview:
The Associate Manager – MSAT Validation will be responsible for ensuring sterile injectable manufacturing processes, equipment, and systems meet stringent validation, compliance, and regulatory requirements. This role involves evaluating manufacturing batches, managing validation activities, and collaborating across technical and quality functions to maintain Pfizer’s operational excellence.
Key Responsibilities:
Review and evaluate clinical and commercial drug batches for compliance with specifications.
Conduct sampling and statistical process control to identify deviations.
Approve and manage investigations, change controls, and compliance documentation.
Provide quality review and oversight of site documentation to meet global standards.
Independently assess Change Control activities for Quality and cGMP impact.
Prepare, execute, and review validation protocols and reports (DQ/FAT/SAT/IQ/OQ/PQ).
Lead validation activities for manufacturing processes, cleaning methods, facilities, utilities, and computerized systems.
Maintain compliance with cGMPs, FDA regulations, ISO guidelines, PDA guidance, GAMP requirements, and 21 CFR Part 11.
Develop and update Validation Master Plans (VMP) and Project Validation Plans (PVP).
Coordinate multi-disciplinary teams for validation projects, ensuring timelines and quality targets are met.
Qualifications – Minimum Requirements:
B.Pharm, M.Pharm, M.S (Pharmacy), M.Sc, or BE.
5–10 years of experience in validation functions for sterile injectable manufacturing.
Proficiency with sterile manufacturing equipment (autoclaves, vial washers, depyrogenation tunnels, filling machines, inspection systems, etc.).
Strong technical skills in validation principles, calibration, and qualification instruments/tools.
Ability to analyze data, identify issues, and recommend corrective actions.
Strong organizational, leadership, and project management abilities.
Excellent written and verbal communication skills; able to interface across departments and levels.
Preferred Requirements:
Experience in plant and technical services operations.
Knowledge of component-level assessments, preventive maintenance requirements, and failure investigations.
Familiarity with terminal sterilization process design, execution, and review.
Work Location Assignment: On Premise
Estimated Salary: ₹16–20 LPA (Based on mid-to-senior validation roles in multinational pharma companies in India)
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