Associate (Quality Assurance – Operations/Compliance/Investigations)

Responsibilities

• Execute and review Quality Assurance activities including document review, shop-floor support, and deviation handling.
• Support Quality Operations by reviewing QC documents, batch records, SOPs, specifications, and study protocols.
• Monitor GMP compliance and perform in-process checks on the shop floor.
• Support Quality Compliance through audit readiness, inspection support, and adherence to cGMP and GDP.
• Assist with quality systems including Change Control, CAPA tracking, and document management.
• Support Quality Investigations by assisting in root cause analysis and tracking investigation closures.

Requirements

• B. Pharm, M. Pharm, or M.Sc. degree.
• 2–3 years of experience with a Master’s degree, or 4–5 years of experience with a Bachelor’s degree.
• Proven experience in Pharma or Biotech QA, QC, or Manufacturing environments.
• Strong knowledge of cGMP, GDP, and regulatory requirements, including 21CFR 211.
• Experience with Change Management processes and Risk Assessment principles.
• Familiarity with manufacturing equipment validation and drug product process validations.
• Ability to communicate effectively across all levels of the organization and work in cross-functional teams.
• Experience facing national or international inspections (e.g., USFDA, MHRA, TGA, or WHO) is a plus.

About the Company

Pfizer is a global leader in the pharmaceutical industry, dedicated to discovering and delivering breakthroughs that change patients' lives. We foster a culture of individual ownership and innovation, seeking talented professionals to join our global community in making the world a healthier place.