Validation Lead / CSV Lead

Job Title: Validation Lead / CSV Lead

Location: Ahmedabad

Experience: 10–15 Years

Job Summary:

We are seeking an experienced Validation Lead with strong expertise in Computer System Validation (CSV) and regulatory compliance within GxP environments. The ideal candidate will have hands-on experience in global implementation/rollout projects and a deep understanding of validation frameworks, regulatory standards, and data integrity principles.

Key Responsibilities:

• Lead and manage end-to-end validation activities for global implementation and rollout projects
• Ensure compliance with regulatory standards including GxP, FDA 21 CFR Part 11, GAMP 5, and Annex 11
• Develop and review validation deliverables such as URS, FS, DS, IQ, OQ, PQ protocols, and reports
• Work on validation of systems like SAP, LIMS, MES, and QMS (e.g., TrackWise)
• Apply risk-based validation approaches and ensure adherence to ALCOA+ data integrity principles
• Collaborate with cross-functional teams including IT, Quality, and Business stakeholders
• Support audits and inspections by regulatory authorities
• Identify risks and implement mitigation strategies throughout the validation lifecycle

Required Skills & Qualifications:

• Strong experience in Computer System Validation (CSV) in regulated industries (Pharma/Life Sciences)
• In-depth knowledge of GxP, FDA 21 CFR Part 11, GAMP 5, and Annex 11
• Hands-on experience with validated systems such as SAP, LIMS, MES, QMS (TrackWise preferred)
• Expertise in risk-based validation methodologies
• Good understanding of ALCOA+ data integrity principles
• Experience in handling global rollouts and multi-region stakeholders

Preferred Qualifications:

• Experience in pharmaceutical or life sciences domain
• Exposure to regulatory audits and compliance inspections
• Strong documentation and stakeholder management skills

Top 3 Mandatory Skills (for screening):

• CSV
• GxP
• Validation