Sr Officer Qa Mumbai

Officer QA Antisera Industry Department: Quality Assurance (QA) Designation: QA Executive Reports To: QA Manager / Head Quality Assurance Job Purpose: To ensure that antisera manufacturing activities are performed in compliance with cGMP, GLP, GDP, and applicable regulatory requirements while maintaining product quality, data integrity, and audit readiness. QA Executives in biologics and antiserum manufacturing typically oversee documentation, in-process quality activities, validation support, CAPA, deviations, and audit compliance. Qualification Activity of equipment systems and instruments. Key Responsibilities Ensure compliance with cGMP, GLP, GDP, and company SOPs.Review and approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).Perform line clearance before manufacturing and packaging activities.Conduct in-process quality assurance (IPQA) checks during production.Prepare, review, and control SOPs, protocols, and quality documents.Handle deviations, change controls, CAPA, and validation documents (Process Validation, Cleaning Validation, Equipment Qualification).Monitor environmental conditions and hygiene compliance.Ensure proper documentation practices and data integrity (ALCOA+).Coordinate internal, vendor, and regulatory audits.Train employees on GMP, SOPs, and quality systems.Ensure timely closure of quality events and audit product release activities as per QA procedures.Educational Qualification M.Sc. (Microbiology / Biotechnology / Biochemistry / Life Sciences) orM.Pharm/B Pharm 25 years of experience in QA within the pharmaceutical, vaccine, biologics, or antiserum industry.Knowledge of GMP documentation, IPQA, validation, and regulatory requirements is preferred.Required Skills Positive Documentation Practices (GDP)cGMP and GLP knowledgeData Integrity (ALCOA+)SOP preparation and reviewAudit handlingCAPA and Deviation ManagementValidation and QualificationStrong communication and analytical skillsMS Office proficiencyKey Performance Indicators (KPIs) Timely review of QA documents.Zero critical GMP closure of deviations and CAPA.Successful internal and external audits.Compliance with documentation timelines.Training completion and effectiveness. Compensation: 15,000.00 - 30,000.00 per month Perks: Adaptable scheduleFood providedPaid sick timeProvident FundWork Location: In person .