? 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 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 quality system improvements.
- Drive process mapping, trend analysis, risk assessments, and continuous improvement initiatives.
- Coordinate with Production, QC, Regulatory Affairs, Marketing, and Packaging Development for effective quality planning.
- Train and mentor QA team members while promoting a culture of quality and compliance. ✅ Preferred Qualifications - Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Microbiology, Biomedical Engineering, or a related discipline.
- Relevant experience in Quality Assurance within the Medical Device or IVD industry.
- Solid knowledge of ISO 13485, WHO Guidelines, EU IVDR, cGMP, and Quality Management Systems.
- Hands-on experience in IPQA, Validation, Vendor Management, CAPA, Change Control, Complaint Handling, Audits, Documentation, and Process Validation.
- Excellent analytical, communication, documentation, and problem-solving skills.

Why Join

Meril?

- Work with a globally recognized Medical Device & IVD organization.
- Exposure to international quality systems and regulatory standards.
- Opportunity to work on innovative diagnostic technologies.
- Collaborative, learning-focused, and growth-oriented work environment. ? Apply Here: https://zfrmz.In/MpmORoBbEJX0nlKMe9cp Know someone who would be a great fit? Like, Share, or Tag them in the comments! #Hiring #QualityAssurance #QA #IVD #MedicalDevices #Diagnostics #ISO13485 #IVDR #WHOGuidelines #cGMP #QualityManagement #IPQA #CAPA #ChangeControl #Validation #VendorManagement #HealthcareJobs #LifeSciences #VapiJobs #GujaratJobs #Meril #CareerOpportunity

📌 Quality Assurance Professional (IVD) (Vapi)
🏢 Meril
📍 Vapi