Associate Manager - MSAT (C&Q)

Responsibilities

• Evaluate, review, and approve validation master plans, protocols, and reports to ensure compliance with company and regulatory standards.
• Troubleshoot validation issues for equipment and performance processes, providing technical expertise for resolution.
• Conduct statistical analysis of testing results and process anomalies to support Quality Investigations.
• Manage routine Quality systems including Change Control, Quality Agreements, Documentation, and Investigations.
• Maintain the Site Validation Master Plan and support regulatory audits by representing engineering validation.
• Support product transfers, new product development, cleaning validation, and deviation investigations.
• Guide the writing and review of validation process documents and technical reports in adherence to Pfizer Quality Standards.

Requirements

• B. Pharm, M. Pharm, B.Tech, or BE degree.
• 6-8 years of experience in Quality Assurance, Validation, or Engineering within a sterile dosage form facility or injectable formulations production.
• Expertise in Good Manufacturing Practices (cGMP) and FDA regulatory guidelines.
• Strong knowledge of validation principles for manufacturing processes, cleaning methods, facilities, equipment, and utility systems.
• Proficiency in executing and reviewing IQ/OQ/PQ protocols and reports.
• Familiarity with GAMP requirements, PDA guidance, ISO guidelines, and 21 CFR part 11.
• Experience with sterile manufacturing equipment such as autoclaves, depyrogenation tunnels, and vial filling machines.
• Ability to perform root cause analysis using DMAIC or other appropriate problem-solving tools.

Preferred Qualifications

• Experience with sterile products and medical devices.
• Strong analytical, organizational, and time management skills.
• Ability to mentor and guide colleagues.
• Experience using AI tools (e.g., ChatGPT or Microsoft Copilot) to enhance productivity and problem-solving.

About the Company

Pfizer is a global leader in the pharmaceutical industry, dedicated to delivering safe and effective products to patients worldwide. Our culture is rooted in science, innovation, and risk-based compliance, aiming to transform lives through groundbreaking therapies.