Associate (Quality Assurance – Operations/ Compliance/ Investigations)

Use Your Power for Purpose

Responsible for execution and review support of Quality Assurance (Operations/ Compliance/ Investigations) activities including document review, shop-floor QA support, deviation handling, and quality systems support to ensure compliance with cGMP and regulatory requirements.

What You Will Achieve

Roles Responsibilities

• Fundamental knowledge of manufacturing and quality control processes (solution preparation, filling, sterilization, visual inspection, packaging)
• Document review and Good Documentation Practices
• Basic knowledge of change control and risk assessment
• Knowledge of chemical and microbiology testing
• Interpersonal Skills: Effective communication with all staff from different levels; builds constructive and effective relationships
• Acts Decisively: Makes decisions in a timely manner based on available information
• Grows Self: Identifies individual development needs and works towards achieving those objectives
• Critical thinking and compliance mindset
• Ability to work in cross-functional teams

Core Responsibilities:

Quality Operations

• Review QC documents (BQ, CQ), batch records, and related documents
• Support shop-floor QA activities including GMP compliance monitoring and process checks
• Perform in-process checks and support batch documentation review
• Review SOPs, specifications, STPs, and study protocols

Quality Compliance

• Support audit activities, inspection readiness, and regulatory commitments
• Ensure adherence to cGMP, GDP, and regulatory requirements
• Support quality systems such as Change Control, CAPA tracking, and document management
• Assist in data integrity and documentation control activities

Quality Investigations

• Support deviation investigations and CAPA implementation
• Assist in root cause analysis using investigation tools
• Track investigation closure within timelines
• Ensure proper documentation of investigation records

Here Is What You Need (Minimum Requirements)

• B. Pharm/M. Pharm/M.Sc.
• Master’s Degree: 2–3 years
• Bachelor’s Degree: 4–5 years
• Experience in Pharma / Biotech QA, QC, or Manufacturing
• Change Management process experience
• Risk assessments principles and tools
• Validation of manufacturing equipment’s
• Drug Product Process validations
• Regulatory requirements
• Compendial Changes
• Knowledge on Regulatory Guidelines, Good documentation practices and Good Manufacturing Practices.
• Thorough understanding of 21CFR 211, Pfizer Quality Standards, site procedures and Processes
• Strong Interpersonal skills
• Ability to communicate effectively with all levels within the organization.
• Compliance driven approach, knowledge on cGMP and regulations.
• Should face national and international inspections such as USFDA, MHRA, TGA & WHO

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

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