Pharm'Up 
BioGenomics Limited, located in Thane, is seeking an experienced and dedicated professional for the position of CQV Lead / QA Validation Expert. This role is crucial for ensuring the company’s equipment, systems, and processes meet global regulatory standards.
Job Description
The selected candidate will lead all Commissioning, Qualification, and Validation (C&Q) activities. Key responsibilities include:
- Validation Leadership: Leading and overseeing C&Q for equipment, utilities, and computerized systems.
- Documentation: Developing and approving validation documents for IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), as well as cleaning and process validation.
- Compliance: Ensuring Computerized System Validation (CSV) compliance with regulations like 21 CFR Part 11 / Annex 11 and supporting IT-QA initiatives.
- Quality Management: Managing risk-based validation, deviations, CAPAs (Corrective and Preventive Actions), and change controls.
- Audit Readiness: Preparing the organization for and supporting inspections from global regulatory bodies such as USFDA, EU-GMP, WHO, and MHRA.
- Collaboration: Working closely with cross-functional teams including Engineering, QA, QC, and IT to ensure the efficient and compliant execution of validation projects.
Candidate Profile
- Experience: A postgraduate degree with a minimum of 10+ years of QA Validation experience in Project, C&Q, Cleaning Validation, Process Validation, and CSV.
- Expertise: Deep knowledge of global GxP regulations (FDA, EMA, WHO, MHRA) is required.
- Skills: The candidate must possess strong project leadership skills and have a proven track record of reducing validation cycle times and achieving zero critical audit findings.
How to Apply
- Location: Thane
- Email: Send your resume to hr@biogenomics.co.in.
- Subject Line: The email subject line must be “CQV LEAD/QA VALIDATION EXPERT- THANE.”
- Application Deadline: The last date to apply is October 10, 2025.
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