Sr. CSV Test & Test Automation Lead/ Manager

Experience: 10+ Years

Location: Pune, Maharashtra

Skills: Computer System Validation (CSV), Quality Compliance, GxP-regulated environments, Medical Devices, Pharmaceuticals, Life Sciences, FDA, EMA, cGMP, GAMP 5, 21 CFR Part 11, 21 CFR Part 820, Annex 11, ISO 13485, ISO 9001, risk-based validation methodologies, FDA Computer Software Assurance (CSA), validation lifecycle management, process validation, equipment qualification (IQ/OQ/PQ), computerized system validation, EDMS, QMS, LIMS, MES, ERP, Test Management tools, Validation Plans, URS, FS, DS, RTM, Protocols, GAMP 5 Practitioner, ASQ Certified Quality Auditor (CQA), PMP, Agile Certification, CSA, CSV Regulatory Training Certifications

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.
Robust 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.

📌 Sr. CSV Test & Test Automation Lead/ Manager (Pune)
🏢 Jade Global Software
📍 Pune