Role:               CSV / Validation Lead – Pharma IT

Location:           REMOTE

Duration:          Long Term Project

Experience:        15+

Client:              Capgemini/End client

Job Role and Responsibilities:

• 15+ years of experience in Pharma IT and SAP environments.

• Strong knowledge of CSV, GxP, and regulatory frameworks.

• Proven leadership in quality assurance and validation.

• Validation Oversight: Author and approve key validation deliverables (e.g., Deliverable Scaling Assessment, CRs, lifecycle documents, test artifacts).

• Strategic Quality Leadership: Define validation strategies with SMEs; assess impact on product quality and data integrity.

• Risk & Compliance Management: Lead and contribute to risk assessments (GxP, cybersecurity, data privacy); ensure validated state and operational compliance.

• Team Guidance & Mentorship: Advise teams on SOPs, CSV processes, and regulatory standards; foster quality culture and process excellence.

Audit & Supplier Engagement: Support internal/external audits; lead audit activities for GxP systems; perform supplier assessments