Associate Manager – Manufacturing Compliance (Sterile Injectables)
Company: Pfizer
Location: Vizag, India
Employment Type: Full-Time | On-site
Job Requisition ID: 4947920
Industry: Pharmaceuticals | Manufacturing Compliance | Quality Assurance
Experience Required: 8+ Years
Job Overview
Pfizer is seeking an experienced Associate Manager – Manufacturing Compliance to support and strengthen compliance across end-to-end sterile injectable manufacturing operations. This role plays a critical part in maintaining Pfizer’s science-driven, risk-based quality culture and ensuring adherence to global regulatory and quality standards. The successful candidate will directly contribute to inspection readiness, quality risk management, and continuous compliance improvement, ultimately safeguarding patient safety.
Key Responsibilities
Manufacturing Compliance & Quality Systems
Implement, maintain, and continuously improve quality systems across sterile manufacturing operations.
Ensure full compliance with Pfizer policies, cGMP requirements, and global regulatory standards including USFDA expectations.
Support inspection readiness activities and participate in internal, regulatory, and RQA audits.
Quality Risk Management & Documentation
Prepare and maintain Quality Risk Assessments for equipment and manufacturing processes.
Track mitigation plans and ensure timely closure of identified risks.
Prepare, review, and approve Master Manufacturing Records (MMRs) and Master Packing Records (MPRs) for commercial, scale-up, validation, and exhibit batches.
Ensure all documentation complies with GDP and ALCOA principles.
Change Control & CAPA Management
Initiate and manage Change Control Forms (CCFs), coordinating with cross-functional teams for impact assessment and approvals.
Monitor CCF-related actions, ensuring timely implementation and closure.
Prepare responses to audit observations and develop Corrective and Preventive Actions (CAPAs) in collaboration with SMEs and QA teams.
Track CAPA effectiveness and provide status updates to stakeholders.
Compliance Oversight & Process Support
Review and approve SOPs, job aids, SOJTs, protocols, and user requirement specifications.
Support investigations, deviations, and quality events to ensure timely resolution.
Review alarm reports, environmental monitoring data, NVPC trends, APQRs, and compliance reports.
Establish alert and action limits for environmental monitoring and contamination control.
Prepare and approve cross-contamination strategies, PCER documents, and validation-related documentation.
Training & Stakeholder Engagement
Deliver Instructor-Led Training (ILT) sessions for colleagues, contractors, and service providers.
Manage classified area access for employees and external personnel.
Ensure walkthrough readiness and document management compliance across manufacturing areas.
Required Qualifications & Experience
Education
Bachelor’s or Master’s degree in Pharmacy or a related discipline.
Experience
Minimum 8 years of experience in Manufacturing Compliance, Quality Assurance, or Manufacturing Operations.
Prior experience in a sterile injectable manufacturing facility is strongly preferred.
Hands-on exposure to IPQA, QMS activities, inspection readiness, and manufacturing compliance.
Key Skills & Competencies
Strong knowledge of cGMP, USFDA regulations, and global compliance standards
Expertise in sterile manufacturing processes and validation activities
Proficiency in Quality Risk Management, Change Control, and CAPA systems
Excellent attention to detail, documentation accuracy, and organizational skills
Strong written and verbal communication abilities
Proficiency in Microsoft Word, Excel, and PowerPoint
Working knowledge of Lean Six Sigma tools and continuous improvement methodologies
Strong analytical and problem-solving skills
Why Join Pfizer
Pfizer is a global leader in pharmaceutical innovation, driven by a commitment to quality, compliance, and patient safety. This role offers the opportunity to work in a high-impact compliance function within a world-class manufacturing environment, contributing directly to the delivery of safe and effective medicines worldwide.
SEO Keywords for Global Visibility
Manufacturing Compliance jobs India, Associate Manager Quality Assurance Pharma, Sterile Injectable Manufacturing Compliance, Pfizer careers Vizag, cGMP Compliance jobs, Pharmaceutical Quality Systems roles.
Equal Opportunity Statement
Pfizer is an equal opportunity employer and is committed to providing a workplace free from discrimination, ensuring equal employment opportunities for all qualified applicants.
Disclaimer
This job description outlines the general responsibilities and requirements of the role and does not represent an exhaustive list of duties. Responsibilities may evolve in line with business and regulatory needs.a
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