Associate Manager - Quality Assurance (Batch release)

Pfizer; Visakhapatnam; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Pfizer is seeking an experienced Quality Assurance/Control professional for on-premise work in Visakhapatnam, India. The role focuses on batch records, product expiration dating, and investigation closure within a GMP/GDP framework.

Collaboration with plant disciplines and strong documentation skills are essential. Experience in sterile injectable environments and auditing is preferred, with proficiency in MS Office/Project and statistical tools.

Qualifications

• B.Pharma, M.Pharma or MSc with 8-10 years of experience in Manufacturing Quality/Quality Control/Production or QA in a pharmaceutical manufacturing facility.

Responsibilities

• Ensure electronic Batch Records/manual batch record audit items are complete/approved per policy.
• Ensure Expiration Date of product/batch as per Marketing authorization.
• Ensure investigations are closed and dispositioned against specified batches.
• Track Quality restrictions/holds.
• Adhere to Safety Procedures/GMP & GDP.
• Interface with plant disciplines to facilitate accumulation, review, correction, and release of manufactured lots.
• Participate in workplace health and safety per company guidelines.

Skills

Technical writing

Communication

Presentation skills

Problem-solving

Team collaboration

Education

B.Pharma / M.Pharma / MSc (8–10 years exp)

Tools

Microsoft Office

Microsoft Project

Statistical Software

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 use

Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.