? 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 innovative 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 Positive 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
📌 Officer / Executive / Assistant Manager- Quality Assurance (Vapi)
🏢 Meril
📍 Vapi