We're Hiring | Quality Assurance Professionals (IVD Industry) /n /n Position: Officer / Executive / Assistant Manager – Quality Assurance (IVD) /n Location: Vapi, Gujarat /n Company: Meril Diagnostic Pvt. Ltd. /n /n 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. /n /n Open Positions /n /n
- Officer – Quality Assurance
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- Executive – Quality Assurance
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- Assistant Manager – Quality Assurance
/n /n /n Key Responsibilities /n Officer / Executive – Quality Assurance /n /n
- Ensure compliance with cGMP, ISO 13485 , and departmental SOPs across manufacturing operations.
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- Perform In-Process Quality Assurance (IPQA) activities, line clearance, and batch record reviews.
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- Monitor manufacturing, dispensing, packing, and environmental conditions to ensure product quality.
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- Prepare and maintain Quality Management System (QMS) documents including SOPs, Change Controls, Deviations, Incidents, OOS/OOT, and Yield Deviations.
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- Review Batch Manufacturing Records (BMRs), analytical records, logbooks, and quality documentation.
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- Support validation and qualification activities.
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- Conduct self-inspections and monitor Good Documentation Practices (GDP).
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- Coordinate with Production, QC, Regulatory Affairs, Packaging Development, and other cross-functional teams to ensure smooth production execution.
/n /n /n Assistant Manager – Quality Assurance /n /n
- Lead Plant QA activities including IPQA, QMS, Vendor Management, Complaint Handling, CAPA, Change Control, CDCR, Process Validation, and Line Clearance .
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- Ensure compliance with ISO 13485, WHO, IVDR, cGMP , and applicable quality standards.
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- Review and approve SOPs,
Batch Manufacturing Records (BMRs), validation protocols, and quality documentation.
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- Manage customer complaints, deviations, investigations, CAPA, recalls, and non-conformances.
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- Lead internal audits, vendor qualification/audits, and quality system improvements.
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- Drive process mapping, trend analysis, risk assessments, and continuous improvement initiatives.
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- Coordinate with Production, QC, Regulatory Affairs, Marketing, and Packaging Development for effective quality planning.
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- Train and mentor QA team members while promoting a culture of quality and compliance.
/n /n /n ✅ Preferred Qualifications /n /n
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Microbiology, Biomedical Engineering , or a related discipline.
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- Relevant experience in Quality Assurance within the Medical Device or IVD industry .
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- Robust knowledge of ISO 13485, WHO Guidelines, EU IVDR, cGMP , and Quality Management Systems.
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- Hands-on experience in IPQA, Validation, Vendor Management, CAPA, Change Control, Complaint Handling, Audits, Documentation, and Process Validation .
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- Excellent analytical, communication, documentation, and problem-solving skills.
/n /n /n Why Join Meril? /n /n
- Work with a globally recognized Medical Device & IVD organization.
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- Exposure to international quality systems and regulatory standards.
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- Opportunity to work on innovative diagnostic technologies.
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- Collaborative, learning-focused, and growth-oriented work environment.
/n /n /n Apply Here: /n /n Know someone who would be a great fit? Like, Share, or Tag them in the comments! /n #Hiring #QualityAssurance #QA #IVD #MedicalDevices #Diagnostics #ISO13485 #IVDR #WHOGuidelines #cGMP #QualityManagement #IPQA #CAPA #ChangeControl #Validation #VendorManagement #HealthcareJobs #LifeSciences #VapiJobs #GujaratJobs #Meril #CareerOpportunity
📌 Officer / Executive / Assistant Manager- Quality Assurance (Vapi)
🏢 Meril
📍 Vapi