Associate Manager - Quality Assurance (Batch release)

Pfizer; India; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Pfizer India is seeking a senior quality professional to oversee batch records, investigations, and expiry date checks for sterile injectable manufacturing. You will coordinate with plant teams to ensure timely batch release and strict adherence to GMP/GDP practices.

You will also monitor quality holds, support audit readiness, and contribute to a compliant, safe manufacturing environment with strong communication and analytical skills.

Qualifications

• B.Pharma, M.Pharma or MSc with 8–10 years of experience in Manufacturing Quality/Quality Control/Production or QA of a pharmaceutical facility.
• Sterile injectable experience is required.
• Fundamental knowledge to operate within narrow boundaries with advanced discipline expertise.

Responsibilities

• Ensure electronic Batch Record/manual batch record Audit items are complete/approved per policy.
• Ensure Expiration Date of product/batch per Marketing authorization.
• Ensure investigations are closed and dispositioned for specified batches.
• Track Quality restrictions/holds and ensure safety procedures adherence.
• Interface with plant disciplines to facilitate batch release.
• Support workplace health and safety compliance per EHS guidelines.

Skills

Technical writing

Communication

Presentation

MS Office

MS Project

Statistical Software

Education

B.Pharma

M.Pharma

MSc

Tools

SAP

GLIMS

AMPS

Job description

**Use Your Power for Purpose**Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety. **What You Will Achieve**In this role, you will:* Ensure that the electronic Batch Record/manual batch record Audit items are complete / approved per applicable policy/procedure.* Ensure Expiration Date of the product/batch as per Marketing authorization specified.* Ensure that all investigations are closed and disposition against the specified batches.* Responsible for tracking of Quality restrictions/holds.* Ensure adherence to Safety Procedures/GMP & GDP Practices.* Interface with necessary plant disciplines to facilitate the accumulation, review, correction, and release of manufactured lots.* Participate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System Manual.**Here Is What You Need** (Minimum Requirements)* B.Pharma, M.Pharma or MSC with 8-10 years of experience in Manufacturing Quality/Quality Control/ Production or in Quality Assurance of a pharmaceutical manufacturing facility.* Sterile injectable experience* Fundamental knowledge of basic work routines and standards sufficient to operate within narrow boundaries. Advanced/well-developed skills and knowledge within a specific professional discipline involving the integration of theory and principles with organizational practices and precedents.* Excellent technical writing, communication, and presentation skills* Proficiency in Microsoft Office, Microsoft Project, and Statistical Software* Experience in preparing and participating in audits and inspections **Bonus Points If You Have** (Preferred Requirements)* Knowledge on SAP, gLIMS and AMPS.* Strong analytical and problem-solving skills* Ability to work independently and as part of a team* Strong interpersonal skills and the ability to communicate effectively with all levels of the organization* Ability to adapt to changing priorities and manage multiple tasks simultaneously* Experience in mentoring and training colleagues* Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical useWork Location Assignment: On Premise