Associate (Quality Assurance – Operations/ Compliance/ Investigations)

Use Your Power for PurposeResponsible 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 AchieveRoles ResponsibilitiesFundamental knowledge of manufacturing and quality control processes (solution preparation, filling, sterilization, visual inspection, packaging)Document review and Good Documentation PracticesBasic knowledge of change control and risk assessmentKnowledge of chemical and microbiology testingInterpersonal Skills: Effective communication with all staff from different levels; builds constructive and effective relationshipsActs Decisively: Makes decisions in a timely manner based on available informationGrows Self: Identifies individual development needs and works towards achieving those objectivesCritical thinking and compliance mindsetAbility to work in cross-functional teamsCore Responsibilities:Quality OperationsReview QC documents (BQ, CQ), batch records, and related documentsSupport shop-floor QA activities including GMP compliance monitoring and process checksPerform in-process checks and support batch documentation reviewReview SOPs, specifications, STPs, and study protocolsQuality ComplianceSupport audit activities, inspection readiness, and regulatory commitmentsEnsure adherence to cGMP, GDP, and regulatory requirementsSupport quality systems such as Change Control, CAPA tracking, and document managementAssist in data integrity and documentation control activitiesQuality InvestigationsSupport deviation investigations and CAPA implementationAssist in root cause analysis using investigation toolsTrack investigation closure within timelinesEnsure proper documentation of investigation recordsHere Is What You Need (Minimum Requirements)B. Pharm/M. Pharm/M.Sc.Master’s Degree: 2–3 yearsBachelor’s Degree: 4–5 yearsExperience in Pharma / Biotech QA, QC, or ManufacturingChange Management process experienceRisk assessments principles and toolsValidation of manufacturing equipment’sDrug Product Process validationsRegulatory requirementsCompendial ChangesKnowledge on Regulatory Guidelines, Good documentation practices and Good Manufacturing Practices.Thorough understanding of 21CFR 211, Pfizer Quality Standards, site procedures and ProcessesStrong Interpersonal skillsAbility 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