Officer / Executive / Assistant Manager- Quality Assurance

Meril · Gujarat, India

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.
• Strong 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.

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