Job Description We're Hiring | Quality Assurance Professionals (IVD Industry)
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n Position: Officer / Executive / Assistant Manager – Quality Assurance (IVD)
n Location: Vapi, Gujarat
n Company: Meril Diagnostic Pvt. Ltd.
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nAre 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.
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n Open Positions
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- Officer – Quality Assurancen
- Executive – Quality Assurancen
- Assistant Manager – Quality Assurancen
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n Key Responsibilities
n Officer / Executive – Quality Assurance
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- Ensure compliance with cGMP, ISO 13485 , and departmental SOPs across manufacturing operations.n
- Perform In-Process Quality Assurance (IPQA) activities, line clearance, and batch record reviews.n
- Monitor manufacturing, dispensing, packing, and environmental conditions to ensure product quality.n
- Prepare and maintain Quality Management System (QMS)
documents including SOPs, Change Controls, Deviations, Incidents, OOS/OOT, and Yield Deviations.n
- Review Batch Manufacturing Records (BMRs), analytical records, logbooks, and quality documentation.n
- Support validation and qualification activities.n
- Conduct self-inspections and monitor Good Documentation Practices (GDP).n
- Coordinate with Production, QC, Regulatory Affairs, Packaging Development, and other cross-functional teams to ensure smooth production execution.n
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n Assistant Manager – Quality Assurance
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- Lead Plant QA activities including IPQA, QMS, Vendor Management, Complaint Handling, CAPA, Change Control, CDCR, Process Validation, and Line Clearance .n
- Ensure compliance with ISO 13485, WHO, IVDR, cGMP , and applicable quality standards.n
- Review and approve SOPs, Batch Manufacturing Records (BMRs), validation protocols, and quality documentation.n
- Manage custome
📌 Officer / Executive / Assistant Manager- Quality Assurance (Vapi)
🏢 Meril
📍 Vapi