Officer / executive / assistant manager- quality assurance

Meril · Vapi, 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 c GMP, 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, c GMP , 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, c GMP , 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: ORo Bb EJX0nl KMe9cp

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