Location: Lucknow, Uttar Pradesh
Company: GeneBio Healthcare Pvt. Ltd.
Industry: Healthcare / IVD (In-Vitro Diagnostics)
Experience Required: Min. 3 years in QA (IVD/Medical Devices preferred)
Job Description: QA Executive – IVD Sector
Are you a Quality Assurance (QA) professional with experience in the IVD (In-Vitro Diagnostics) or Medical Devices sector? GeneBio Healthcare Pvt. Ltd., a leading healthcare company in Lucknow, UP, is hiring a QA Executive to ensure compliance with ISO 13485, ICMR, and CDSCO regulations.
Key Responsibilities:
✔ Implement and maintain Quality Management System (QMS) as per ISO 13485 & regulatory standards
✔ Review and approve batch manufacturing & QC documents
✔ Manage non-conformance, CAPA (Corrective & Preventive Actions), and change controls
✔ Support internal & external audits (regulatory & customer audits)
✔ Ensure compliance with IVD documentation practices & data integrity
✔ Collaborate with R&D, Production, and Regulatory Affairs teams
Required Skills & Qualifications:
✔ Bachelor’s/Master’s in Life Sciences, Biotechnology, or related field
✔ 3+ years of QA experience (preferably in IVD/Medical Devices/Healthcare)
✔ Strong knowledge of ISO 13485, ICMR, CDSCO guidelines
✔ Expertise in CAPA management, root cause analysis, and deviation handling
✔ Proficiency in QA documentation tools & software validation
✔ Excellent analytical, problem-solving, and communication skills
Why Join GeneBio Healthcare?
✔ Work on cutting-edge diagnostic solutions in the IVD sector
✔ Learning-driven and growth-oriented work environment
✔ Competitive salary & benefits
How to Apply?
If you meet the qualifications and are excited about this opportunity, send your updated resume to:
📧 hr@genebiohealthcare.com
Subject Line: “Application for QA Executive – IVD Sector, Lucknow”
