Officer / Executive / Assistant Manager - Quality Control (IVD)

About the Role

Meril Diagnostic Pvt. Ltd. invites dedicated professionals to join their Quality Control team specializing in In Vitro Diagnostics (IVD) at their facility in Vapi, Gujarat. This opportunity includes positions at Officer, Executive, and Assistant Manager levels focused on ensuring the excellence and compliance of diagnostic products critical to healthcare.

Key Responsibilities

• Conduct quality control analyses on Rapid Diagnostic Kits, hematology reagents, raw materials, semi-finished, and finished products, including tests for diseases like Malaria, HIV, HBsAg, Syphilis, Dengue, HCV, and others.
• Perform accelerated and real-time stability studies according to approved protocols while managing laboratory instrumentation and maintaining accurate equipment usage logs.
• Prepare comprehensive test reports and ensure all documentation adheres to regulatory and quality standards.
• Maintain laboratory cleanliness and sample storage as per Standard Operating Procedures (SOPs) and support WHO Prequalification studies and routine lab activities.
• Lead QC testing for various assay platforms such as Rapid Tests, ELISA Kits, Blood Grouping Sera, and Flow-through Assays, with oversight on data review, report approvals, and batch release timelines.
• Ensure compliance with critical regulations including ISO 13485, current Good Manufacturing Practices (cGMP), CDSCO mandates, and proper documentation practices.
• Manage deviations through OOS/OOT investigations, implement CAPA, oversee calibration, validation, and environmental monitoring processes, while supervising QC laboratory operations.
• Guide and develop QC team members by providing technical training and fostering their competency growth.
• Collaborate closely with Quality Assurance, Production, and Research & Development teams on technology transfers, validations, and continuous improvement initiatives.

Preferred Qualifications and Skills

• Proven experience within the In Vitro Diagnostics (IVD) industry, particularly with Rapid Diagnostic Kits, ELISA, Blood Grouping Sera, Flow-through Assays, or immunology-related products.
• In-depth knowledge of ISO 13485 standards, GMP protocols, CDSCO regulations, and laboratory documentation procedures.
• Strong analytical aptitude, effective communication abilities, and solid problem-solving skills.