Associate Manager – Manufacturing Compliance
Location: Visakhapatnam (Vizag), India
Employment Type: Full-Time
Job Requisition ID: 4950594
Industry: Pharmaceutical Manufacturing | Quality Assurance | Compliance
About Pfizer
At Pfizer, our mission is to deliver safe, effective, and high-quality medicines to patients worldwide. Guided by a science-driven, risk-based quality culture, we prioritize patient safety, operational excellence, and regulatory compliance across all manufacturing processes. Join a global leader in healthcare and make a direct impact on patient care while advancing your career in pharmaceutical manufacturing compliance.
Role Overview
Pfizer is seeking an Associate Manager – Manufacturing Compliance to oversee and maintain compliance across end-to-end sterile injectable manufacturing operations. This role will be responsible for ensuring inspection readiness, quality system implementation, regulatory adherence, and continuous improvement of manufacturing and operational processes.
The ideal candidate will have 6+ years of experience in manufacturing or quality assurance within sterile injectable production and possess a strong understanding of cGMP, USFDA regulations, and operational quality systems.
Key Responsibilities
Quality Systems & Compliance
Implement, maintain, and monitor quality systems to ensure full compliance across manufacturing operations
Lead inspection readiness activities and ensure processes align with Pfizer policies and regulatory requirements
Prepare, review, and approve Master Manufacturing Records (MMRs) and Master Packing Records (MPRs) for commercial, scale-up, and validation batches
Maintain all documentation in accordance with GDP and ALCOA principles
Initiate, track, and close Change Control Forms (CCFs), coordinating with cross-functional teams for impact assessment and approval
Review, approve, and maintain SOPs, job aids, and SOJTs in PDOCS
Risk Management & Investigations
Prepare Quality Risk Assessments for equipment and processes, track mitigation plans, and ensure timely closure
Support investigations, track Corrective and Preventive Actions (CAPAs), and provide updates to stakeholders
Develop, review, and approve protocols, user requirement specifications, and cross-contamination strategies
Operational Oversight
Monitor Environmental Monitoring, NVPC trends, and alarm reports, ensuring compliance with PQS, CAS, and compendial requirements
Deliver Instructor-Led Training (ILT) sessions to colleagues and service providers
Participate in regulatory audits and RQA inspections, ensuring all findings are addressed and closed appropriately
Collaboration & Leadership
Manage classified area access for employees, service providers, and contractors
Collaborate with cross-functional teams to maintain operational quality standards and support continuous improvement initiatives
Required Qualifications & Experience
Master’s or Bachelor’s degree in Pharmacy
6+ years of experience in manufacturing or quality assurance in sterile injectable facilities
Strong knowledge of USFDA regulatory requirements, cGMP compliance, and QMS operations
Extensive experience with inspection readiness, IPQA activities, and manufacturing operations
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
Strong organizational skills, attention to detail, and excellent written and verbal communication
Familiarity with Lean Six Sigma tools is preferred
Preferred Skills
In-depth understanding of sterile injectable manufacturing processes and procedures
Knowledge of validation, audit techniques, and statistical applications
Experience with audit processes, CAPA implementation, and regulatory inspections
Strong problem-solving and decision-making skills
Knowledge of drug product requirements and regulatory documentation standards
Work Location
On-Premise – Pfizer Manufacturing Site, Visakhapatnam (Vizag), India
Why Join Pfizer?
Opportunity to directly impact patient care through operational excellence
Exposure to global pharmaceutical manufacturing practices and regulatory compliance standards
Collaborative environment fostering career growth and professional development
Work with a world-class quality and compliance team committed to innovation and safety
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.a
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