Senior Executive
2 weeks ago
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.
 
- 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.
 
7 to 10 years of hands-on experience in CSV within a regulated pharmaceutical or biotech environment.
EducationB.Tech Graduation Competencies
Stakeholder Management Strategic Agility Customer Centricity Innovation & Creativity Collaboration Result Orientation Process Excellence Developing Talent
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