Associate (Quality Assurance – Operations/ Compliance/ Investigations)

Job description

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. 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