BioGenomics Limited are on the lookout for dedicated professionals to join our growing organization.
Post : CQV Lead / QA Validation Expert
Job Description
• Lead Commissioning, Qualification & Validation (C&Q) activities for equipment, utilities, and computerized systems.
• Develop & approve IQ, OQ, PQ, cleaning validation, process validation, and CPV documentation.
• Oversee CSV compliance as per 21 CFR Part 11 / Annex 11 and support IT-QA initiatives.
• Manage risk-based validation, deviations, CAPAs, and change controls.
• Ensure audit readiness and support USFDA, EU-GMP, WHO, and MHRA inspections.
• Collaborate with Engineering, QA, QC, and IT teams to deliver compliant, efficient validation projects.
Candidate Profile
• Post Graduate with 10+ years of QA Validation experience in Project, C&Q, Cleaning Validation, Process Validation, CSV.
• Expertise In global GxP regulations (FDA, EMA. WHO, MHRA).
• Strong project leadership skills with proven success in reducing validation cycle times and achieving zero critical audit findings.
Location : Thane
SEND YOUR CV WITH EMAIL SUBJECT LINE : CQV LEAD/QA VALIDATION EXPERT- THANE
E-Mail ID : hr@biogenomics.co.in
Last Date : 10th October 2025
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