Quality Assurance Officer / Executive / Assistant Manager

About the role

Meril Diagnostic Pvt. Ltd. is seeking qualified professionals for Officer, Executive and Assistant Manager positions in Quality Assurance within the In Vitro Diagnostics (IVD) sector. The role involves ensuring compliance with global quality standards and supporting the delivery of innovative diagnostic solutions.

Key responsibilities

• Ensure compliance with cGMP, ISO 13485, WHO guidelines, EU IVDR and internal SOPs across manufacturing operations.
• Perform In‑Process Quality Assurance (IPQA) activities, line clearance, batch record reviews and monitor manufacturing, dispensing, packing and environmental conditions.
• Prepare and maintain QMS documentation including SOPs, change controls, deviations, incidents, OOS/OOT and yield deviations.
• Review Batch Manufacturing Records, analytical records, logbooks and support validation and qualification activities.
• Conduct self‑inspections, monitor Good Documentation Practices (GDP) and coordinate with Production, QC, Regulatory Affairs and other cross‑functional teams.
• For Assistant Manager level: lead plant QA activities, manage vendor qualification, complaint handling, CAPA, internal audits and drive continuous improvement initiatives.

Required profile

• 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 with IPQA, validation, vendor management, CAPA, change control, complaint handling, audits and process validation.
• Excellent analytical, documentation and problem‑solving abilities.

Required skills

• cGMP
• ISO 13485
• WHO Guidelines
• EU IVDR
• Good Documentation Practices (GDP)
• In‑Process Quality Assurance (IPQA)
• Validation and qualification
• Vendor management
• CAPA
• Change control
• Complaint handling
• Audits
• Process validation
• Quality Management System documentation

What we offer

• Opportunity to work with a globally recognized medical device and IVD organization.
• Exposure to international quality systems and regulatory standards.