CSV (Computer Systems Validation) Manager
PuneFull-time7–9 yrsPosted 4 months ago
Senior legal role at Transperfect in Pune. Needs 7–9 years and a B.Tech, B.E. or B.Sc.
About the role
The CSV (Computer Systems Validation) Manager, Trial Interactive leads and advances TransPerfect's global Life Sciences compliance initiatives, including 21 CFR Part 11, GCP/ICH requirements, and the company's ISO 9001-certified Quality Management System (QMS).
What you'll do
- Serving as the primary subject matter expert (SME) and point of escalation during client audits, regulatory inspections, and internal quality reviews
What you need
- Compliance
- Documentation
- Technical writing
- ISO 9001
- GCP
- Vulnerability assessment
Good to have
- SOP writing