We're Hiring | Quality Assurance Professionals (IVD Industry) Position: Officer / Executive / Assistant Manager – Quality Assurance (IVD) Location: Vapi, Gujarat Company: Meril Diagnostic Pvt. Ltd. Are you passionate about driving quality excellence in the In Vitro Diagnostics (IVD) industry? Join Meril Life Sciences and play a key role in ensuring compliance with global quality standards while contributing to cutting-edge diagnostic solutions that impact lives worldwide. Open Positions Officer – Quality Assurance Executive – Quality Assurance Assistant Manager – Quality Assurance Key Responsibilities Officer / Executive – Quality Assurance Ensure compliance with cGMP, ISO 13485 , and departmental SOPs across manufacturing operations. Perform In-Process Quality Assurance (IPQA) activities, line clearance, and batch record reviews. Monitor manufacturing, dispensing, packing, and environmental conditions to ensure product quality. Prepare and maintain Quality Management System (QMS) documents including SOPs, Change Controls, Deviations, Incidents, OOS/OOT, and Yield Deviations.
Review Batch Manufacturing Records (BMRs), analytical records, logbooks, and quality documentation. Support validation and qualification activities. Conduct self-inspections and monitor Good Documentation Practices (GDP). Coordinate with Production, QC, Regulatory Affairs, Packaging Development, and other cross-functional teams to ensure smooth production execution. Assistant Manager – Quality Assurance Lead Plant QA activities including IPQA, QMS, Vendor Management, Complaint Handling, CAPA, Change Control, CDCR, Process Validation, and Line Clearance . Ensure compliance with ISO 13485, WHO, IVDR, cGMP , and applicable quality standards. Review and approve SOPs, Batch Manufacturing Records (BMRs), validation protocols, and quality documentation. Manage customer complaints, deviations, investigations, CAPA, recalls, and non-conformances. Lead internal audits, vendor qualification/audits, and qual
📌 Officer / Executive / Assistant Manager- Quality Assurance (Gujarat)
🏢 Meril
📍 Gujarat