Associate Manager MQA

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

Job summary

Pfizer is seeking an experienced Quality Assurance professional in India to ensure cGMP compliance across Terminal Sterilization, Visual Inspection and Packaging.

Role involves reviewing batch records, performing sampling, and ensuring adherence to Pfizer standards while coordinating with cross-functional teams to uphold product quality and patient safety.

Qualifications

• B. Pharm, M. Pharm, MSc.
• 6-8 years of experience in Manufacturing Quality Assurance / QA / Production in a pharmaceutical facility.
• Fundamental knowledge of terminal sterilization, Visual Inspection and Packaging; capable of handling regulatory inspections (USFDA/MHRA/TGA).
• Ability to work effectively within own team and cross-functional teams.
• Proactive problem-solving and effective communication across staff levels.

Responsibilities

• Ensure cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.
• Maintain regulatory compliance per cGMP practices and Pfizer standards.
• Review Batch reports and equipment audit trails; perform sampling and record results in Batch records.
• Lead start-up/end activities, sensor challenges, and recipe reviews; conduct daily walkthroughs and report observations.
• Assess equipment alarms and downtime impacts with guidance from senior team lead.

Skills

Problem Solving

Interpersonal Skills

Regulatory Inspections

Education

Bachelor/Master in Pharmacy or MSc

Tools

Microsoft Excel

Microsoft Word

Job description

Use Your Power for Purpose

Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

What You Will Achieve

In this role, you will:

• Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.
• Maintain regulatory compliance in accordance with cGMP practices
• Ensure manufacturing policies and procedures conform to Pfizer standards.
• Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Team leader.
• Review of Batch reports, and Equipment audit trails
• Perform Acceptable Quality level sampling, Inspection and record the results in Batch records for all products.
• Perform batch start-up and end activities viz. sensor challenge tests, recipe review etc.
• Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging.
• Perform Daily walkthroughs and report observations to the Sr. Team leader.
• Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Team Leader.
• Review and assessment of equipment alarms and review of quarterly alarm trends.
• Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
• Identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime, and increase the Efficiency. AMPS Recipe review and validation of recipe.
• Experience in handling regulatory, corporate and internal auditors/ inspectors

Here Is What You Need (Minimum Requirements)

• B. Pharm, M. Pharm, MSc.
• 6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.
• Fundamental knowledge of terminal sterilization process/ Visual Inspection/Packaging.Should be capable of handling regulatory inspections USFDA/MHRA/TGA, etc,
• Ability to work effectively within own team and interdepartmental teams
• Good working knowledge of Microsoft Excel and Word
• Proactive approach to problem-solving
• Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship
• Acts Decisively: Makes decision in a timely manner based on available information
• Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives Critical thinking and Compliance mind set.

Bonus Points If You Have (Preferred Requirements)

• Experience in quality administered systems
• Strong organizational skills and attention to detail
• Experience with regulatory compliance and documentation
• Ability to mentor and review the work of other 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

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