Senior Team Leader – Manufacturing Compliance
📍 Location: Vizag, India (On-site)
🕒 Experience: 6–8+ Years (Sterile Pharma Manufacturing, cGMP, Regulatory Compliance)
💼 Industry: Pharmaceutical Manufacturing / Quality & Compliance / Regulatory Affairs
🏢 Company: Pfizer
Salary: ₹12 – ₹18 LPA (Estimated based on experience and Vizag pharma industry benchmarks)
About the Role:
Pfizer is hiring a Senior Team Leader – Manufacturing Compliance at its Vizag facility to oversee quality systems, regulatory compliance, and manufacturing documentation in a sterile pharmaceutical environment. You will lead a team to ensure cGMP adherence, inspection readiness, and operational excellence, directly contributing to Pfizer’s mission of delivering safe, effective, and high-quality medicines worldwide.
Key Responsibilities:
Lead downstream manufacturing compliance activities.
Maintain Quality Management Systems in alignment with cGMP and global regulatory requirements.
Manage the Change Control Management System, including impact assessments, approvals, and closure tracking.
Coordinate CAPA identification and implementation to address investigation findings.
Review and approve Master Manufacturing Records for commercial, scale-up, exhibit, and validation batches.
Oversee quality risk assessments for equipment and processes.
Ensure compliance with audit observations and track action item implementation.
Monitor training compliance for all production staff, ensuring no overdue items.
Review compendial assessments, APQR, trend reports, and deviation closures.
Facilitate documentation issuance, retrieval, and control in coordination with QA and production teams.
Support inspection readiness by monitoring regulatory commitments and action items.
Conduct gap assessments and implement corrective actions for regulatory requirements.
Drive SOP compliance, quality systems adherence, and safety system implementation.
Lead responses to market complaints, identify root causes, and implement CAPA.
Manage and develop team members, including performance evaluations and coaching.
Qualifications & Experience Required:
Postgraduate in Science/Pharmacy with 6+ years OR B.Pharm with 8+ years in quality and compliance roles in sterile manufacturing.
Proven experience preparing for FDA, EMA, or other regulatory inspections.
Strong project management skills and ability to handle multiple priorities.
Proficiency in Microsoft Office tools.
Excellent written and verbal communication skills.
Strong problem-solving abilities with a customer-focused mindset.
Preferred Skills:
Experience in people management and leadership roles.
Deep knowledge of pharmaceutical quality systems.
Strong negotiation and influencing skills.
Strategic thinking and ability to advise on enterprise initiatives.
Proven track record of driving compliance and inspection readiness programs.
What Pfizer Offers:
Competitive salary and performance incentives.
Comprehensive health and insurance benefits.
Leadership development opportunities in a global organization.
Inclusive and diverse workplace culture.
Join Pfizer as a senior leader in manufacturing compliance and ensure the highest quality standards in life-saving medicines.
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