Job Description We're Hiring | Quality Assurance Specialists (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 Valuable 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