The Senior Quality Assurance Specialist (Rapid Test Kits) oversees the quality management and regulatory compliance for the development, manufacturing, and packaging of In Vitro Diagnostic (IVD) rapid lateral flow test kits. This role ensures all processes meet stringent ISO 13485 and FDA regulations, driving the secure and compliant release of diagnostic products to the market.Key Responsibilities
- IVD Compliance & QMS: Maintain and enforce the Quality Management System (QMS) specifically for medical devices, handling CAPAs, deviations, and change controls related to kit production.
- Batch Release & Inspection: Review and approve batch manufacturing records, raw material testing, and final product release criteria for rapid test kits.
- Validation Oversight: Oversee validation protocols for automated assembly lines, packaging, chemical formulation, and shelf-life stability testing.
- Audits & Risk Management:
Lead internal and supplier audits, and maintain the product risk management file according to ISO 14971.
- Regulatory Alignment: Ensure design history files (DHF) and device master records (DMR) are audit-ready for regulatory inspections.
Qualifications:
- Education: Bachelor’s degree in Biochemistry, Biotechnology, Bioengineering, or a related field.
- Experience: 5+ years of QA experience strictly within medical devices or diagnostics, with specific exposure to lateral flow assays or rapid test kit manufacturing.
- Standards: In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and CE-IVDR requirements.
Pay: ₹25,000.00 - ₹50,000.00 per month
Benefits:
- Leave encashment
- Paid sick time
- Provident Fund