Want to know if this job is worth applying to?
Maharashtra, India
Onsite
Senior Computer System Validation (CSV) Lead / Manager – 10+ Years Experience
Experience: 10+ Years
Domain: Medical Devices / Pharma / Life Sciences
Location: Flexible
Key Responsibilities & Qualifications
10+ years of hands-on experience in Computer System Validation (CSV), Quality Compliance, and GxP-regulated environments, including Medical Devices, Pharmaceuticals, and Life Sciences.
Expert knowledge of FDA, EMA, cGMP, GAMP 5, 21 CFR Part 11, 21 CFR Part 820, Annex 11, ISO 13485, and ISO 9001 regulations, with proven experience leading validation and compliance programs.
Strong experience in risk-based validation methodologies, including FDA Computer Software Assurance (CSA), validation lifecycle management, process validation, equipment qualification (IQ/OQ/PQ), and computerized system validation.
Hands-on expertise with EDMS, QMS, LIMS, MES, ERP, and Test Management tools, including authoring, reviewing, and approving validation deliverables such as Validation Plans, URS, FS, DS, RTM, Protocols, and Summary Reports.
Demonstrated leadership and stakeholder management skills, capable of leading global validation teams, driving audit readiness, supporting regulatory inspections, and ensuring compliance across enterprise-wide GxP systems.
Preferred Certifications:
GAMP 5 Practitioner
ASQ Certified Quality Auditor (CQA)
PMP / Agile Certification (Preferred)
CSA / CSV Regulatory Training Certifications
