Explore Pfizer Hiring for Associate Manufacturing Compliance role in Vizag, covering responsibilities, qualifications, compliance requirements
Pfizer, one of the world’s leading pharmaceutical manufacturers, is inviting applications for the position of Associate – Manufacturing Compliance at its Vizag facility in India. This opportunity is ideal for candidates with strong experience in sterile injectable manufacturing, quality assurance, or regulatory compliance. This long-format post covers job responsibilities, educational qualifications, required skills, organizational expectations, and a complete guide on how to apply. Pfizer Hiring for Associate Manufacturing Compliance
Pfizer’s mission is to deliver safe, effective, and high-quality medical products to patients worldwide. Every employee contributes directly to this vision. The Associate – Manufacturing Compliance plays a critical role in maintaining compliance standards, executing documentation activities, managing change controls, monitoring corrective actions, and ensuring that all manufacturing processes align with regulatory expectations. Pfizer Hiring for Associate Manufacturing Compliance
About Pfizer
Pfizer is a global biopharmaceutical company known for innovative medicines, cutting-edge research, and robust manufacturing capabilities. With a long-standing commitment to product quality, regulatory compliance, and technological excellence, Pfizer’s manufacturing sites follow stringent quality practices. The Vizag facility is an important sterile injectable manufacturing site involved in delivering life-saving medicines to global markets. Pfizer Hiring for Associate Manufacturing Compliance
Pfizer emphasizes a science-driven, risk-based, and compliant quality culture. Employees are encouraged to work with integrity, excellence, accountability, and transparency. Working at Pfizer means joining a team that impacts millions of patient lives through world-class healthcare solutions. Pfizer Hiring for Associate Manufacturing Compliance
Job Title: Associate – Manufacturing Compliance
Location: Vizag, India
Job Type: Full-Time
Job Requisition ID: 4945734
Work Assignment: On-Premise
Posted: Today
Use Your Power for Purpose
Pfizer describes this role as one aligned with its purpose-driven culture. Whether your expertise lies in quality, compliance, or manufacturing, your contribution directly influences patient safety and regulatory reliability. Pfizer’s quality systems are built on flexibility, innovation, and consistency. Employees in this role help maintain a compliant environment that ensures safe and effective products are delivered worldwide. Pfizer Hiring for Associate Manufacturing Compliance
What You Will Achieve
As an Associate in Manufacturing Compliance, you will be responsible for developing, managing, and maintaining standard procedures, quality systems, and documentation that ensure compliance with regulatory expectations and Pfizer’s quality guidelines. You will actively participate in quality risk management, change control, CAPA tracking, and audit readiness. Pfizer Hiring for Associate Manufacturing Compliance
This role demands a deep understanding of sterile injectable manufacturing processes, regulatory requirements, and GMP standards. Through detailed documentation oversight, cross-functional communication, and strong analytical skills, you will help safeguard product integrity and strengthen the site’s compliance posture. Pfizer Hiring for Associate Manufacturing Compliance
Detailed Job Responsibilities
Below is an exhaustive breakdown of what the role entails:
1. Quality Risk Management
- Prepare and maintain Quality Risk Assessments (QRAs) for equipment and manufacturing processes.
- Track and monitor mitigation plans, ensuring timely closure of risks identified through assessments.
2. Documentation Review and Approval
You will handle documentation associated with multiple stages of manufacturing, including: Pfizer Hiring for Associate Manufacturing Compliance
- Preparing, reviewing, and approving Master Manufacturing Records (MMRs)
- Reviewing and approving Master Packing Records (MPRs)
- Managing documents for commercial, scale-up, exhibit, intended, and validation batches
- Ensuring compliance with GDP (Good Documentation Practices) and ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate)
3. Change Control Management
- Initiate Change Control Forms (CCFs) in coordination with cross-functional teams.
- Ensure proper impact assessment and route controls to necessary stakeholders.
- Update procedures based on approved CCFs.
- Upload revised procedures and track them through the Pfizer Learning System (PLS).
- Ensure timely closure of all CCF-related action items.
4. CAPA and Audit Management
- Prepare responses for audit observations in consultation with subject matter experts and QA leads.
- Propose and track Corrective and Preventive Actions (CAPAs).
- Provide updates to stakeholders until completion.
- Support investigations related to deviations, complaints, or process failures.
- Assist in preparing documentation for regulatory inspections and internal RQA audits.
5. SOP and Training Management
- Review and approve SOPs, job aids, and SOJTs through the PDOCS system.
- Serve as either the primary or secondary document owner depending on assignment.
- Deliver Instructor-Led Training (ILT) sessions to employees and service providers.
6. Protocols and Validation Support
- Prepare and execute protocols, user requirement specifications, and validation documents as required.
- Support qualification processes and ensure that all validation activities align with compendial and PQS guidelines.
7. Facility, Equipment, and Environmental Monitoring Oversight
Responsibilities include:
- Reviewing and approving alarm reports, conductivity reports, NVPC (Non-Viable Particle Count) trending, and APQR reports
- Verifying NVPC monitoring activities for compliance
- Assessing PQS, compendial, and CAS requirements
- Establishing alert and action levels for Environmental Monitoring
- Managing access to controlled areas for colleagues, contingent workers, and approved vendors
8. Cross-Contamination and Quality Strategy
- Prepare, review, and approve cross-contamination strategy documents
- Review and maintain Product Contact Equipment Risk (PCER) documents
- Ensure process simplification, waste elimination, and continuous improvement
9. Walkthrough Compliance and Documentation Integrity
- Conduct walkthrough audits of manufacturing areas
- Monitor documentation compliance in alignment with GDP and ALCOA
- Initiate corrective actions where necessary
Minimum Qualifications Required
To apply for this position, candidates must have: Pfizer Hiring for Associate Manufacturing Compliance
- Bachelor’s or Master’s degree in Pharmacy
- Minimum 2+ years of relevant experience in:
- Manufacturing
- Quality Assurance
- Sterile injectable manufacturing site operations
- Strong understanding of USFDA regulatory requirements, cGMP, and compliance standards
- Excellent organizational, written, and verbal communication skills
- Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)
- Knowledge of Lean Six Sigma tools
Additional Preferred Qualifications
Candidates who possess the following skills will have an added advantage: Pfizer Hiring for Associate Manufacturing Compliance
- Hands-on experience in sterile injectable manufacturing
- Knowledge of GMP, validation, audit techniques, and process statistics
- Experience handling audit processes, observations, and CAPA implementation
- Strong analytical and problem-solving abilities
- Good understanding of drug product quality requirements
Pfizer’s Equal Opportunity Commitment
Pfizer follows a strict equal employment opportunity policy and maintains a workplace that is free from discrimination. All candidates, regardless of gender, religion, disability, nationality, or veteran status, receive fair consideration. Pfizer encourages eligible candidates from diverse backgrounds to apply. Pfizer Hiring for Associate Manufacturing Compliance
How to Apply – Step-by-Step Guide
If you wish to apply for the Associate – Manufacturing Compliance position at Pfizer Vizag, follow the steps below: Pfizer Hiring for Associate Manufacturing Compliance
- Visit the official Pfizer Careers Portal.
- Search for the Job ID: 4945734.
- Select the posting titled Associate – Manufacturing Compliance and location: Vizag, India.
- Click on the Apply button to start your application.
- Create a login or use your existing account.
- Fill out the online application form with accurate personal and professional details.
- Upload your updated resume and relevant certificates.
- Review the application and submit it.
Once submitted, Pfizer’s recruitment team will contact shortlisted candidates for further assessment. Pfizer Hiring for Associate Manufacturing Compliance
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