CSV Engineer
PuneFull-time5–9 yrsPosted 4 weeks ago
Senior pharma quality role at Aligned Automation Services in Pune. Needs 5+ years and a B.Tech, B.E. or B.Sc.
About the role
We are seeking an experienced CSV Engineer to the pharmaceutical manufacturing area. This role will be responsible for compliance with industry regulations including 21 CFR Part 11, EU Annex 11, and This role combines leadership in CSV practices with cross-functional teams across IT, Quality, Manufacturing, and Engineering.
What you'll do
- Validation Leadership & QA Testing
- And approve SDLC deliverables and validation documentation for
- The development and execution of validation test plans and test scripts
- For system implementations and changes
- Quality Assurance leadership in testing activities, including defect
What you need
- Documentation
- Test cases
- SOP writing
- Communication