Senior Executive

Job Description

We are seeking a skilled CSV SME to lead and manage Computer System Validation (CSV) activities in compliance with GxP, cGMP, and global regulatory standards (GAMP5, 21 CFR Part 11, EU Annex-11, WHO Annex-5). The ideal candidate will ensure robust validation, documentation, and lifecycle management of GxP computerized systems across Quality, R&D, and Manufacturing domains.

Key Responsibilities:

Quality & Compliance:

• Ensure adherence to cGMP, GxP, EH&S, and other regulatory requirements.
• Conduct and supervise tasks per SOPs; report deviations and quality concerns.
• Monitor training compliance and support audit readiness.

Technical & CSV Responsibilities:

• Lead CSV activities including URS, FRS, DCS, IQ/OQ/PQ, Risk Assessments, and Traceability Matrix.
• Manage validation deliverables and ensure documentation aligns with regulatory expectations.
• Oversee periodic reviews, change controls, CAPAs, and system retirements.
• Maintain inventory and indexing of GxP systems and ensure secure data management.
• Provide training on CSV principles and regulatory guidelines.

Work Experience

7 to 10 years of hands-on experience in CSV within a regulated pharmaceutical or biotech environment.

Education

Competencies