Associate Manager - QA

Roles & Responsibilities
• Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications
• Perform sampling activities and apply statistical process control to identify deviations and trends
• Ensure cGMP and GxP compliance across Terminal Sterilization, Visual Inspection, and Packaging operations
• Act as Subject Matter Expert (SME) for Terminal Sterilization, Visual Inspection, and Packing processes
• Review electronic Batch Records (eBR) and assess quality impact
• Perform daily walkthroughs, random process checks, and report observations with timely closure
• Investigate Quality Assurance deviations, lead and support CAPA implementation, and escalate critical issues to QA leadership
• Independently assess Change Control activities for quality and operational GMP impact
• Review site documentation to ensure alignment with Pfizer global quality and regulatory standards
• Provide training to colleagues on downstream processes and equipment
• Support and lead moderate to complex quality projects with effective planning and execution
• Participate in process and procedure simplification initiatives to reduce downtime and improve efficiency
• Support audits and inspections by regulatory, corporate, and internal agencies

Qualifications
• B.Pharm / M.Pharm / M.Sc (Any specialization)

Experience
• 8–10 years of experience in Manufacturing Quality Assurance, Quality Assurance, or Production within a pharmaceutical manufacturing facility

Skills
• Strong understanding of cGMP, GxP regulations, and pharmaceutical quality systems
• Hands-on experience in downstream manufacturing QA operations
• Proven troubleshooting abilities in manufacturing environments
• Experience handling regulatory, corporate, and internal audits/inspections
• Strong critical thinking and problem-solving skills
• Ability to work effectively within cross-functional and interdepartmental teams
• Good working knowledge of Microsoft Excel and Word
• Proactive mindset with attention to detail and compliance
• Ability to mentor colleagues and review others’ work
• Exposure to quality-administered systems and regulatory documentation
• Familiarity with responsible use of AI tools (e.g., ChatGPT, Microsoft Copilot) for productivity and problem-solving is an added advantage

About the Organization
Pfizer is a global pharmaceutical leader driven by science, innovation, and a strong quality-first culture. With a patient-centric and risk-based compliance approach, Pfizer empowers professionals to make a direct impact on global healthcare by delivering safe, effective, and high-quality medicines worldwide.