Senior Computer System Validation (CSV) / CSA Lead
PuneFull-time20–30 yrsPosted 5 months ago
Leadership pharma quality role at Aligned Automation Services in Pune. Needs 20+ years and a B.Tech, B.E. or B.Sc.
About the role
We are seeking an experienced Senior CSV / CSA Lead to manage validation, compliance, and lifecycle governance of GxP-regulated computerized systems within a pharmaceutical manufacturing environment. The role requires deep expertise in Computer System Validation (CSV), Computer Software Assurance (CSA), Software Validation, Data Integrity, and end-to-end qualification activities including IQ/OQ/PQ.
What you'll do
- Lead end-to-end CSV and CSA lifecycle activities for GxP computerized systems
- Author, review, and approve: Validation Plans
- URS / FS / DS documents
- SOPs and Work Instructions
- Execute and oversee qualification activities including IQ, OQ, PQ, FAT, SAT, and commissioning support
What you need
- SOP writing
- SCADA
- ERP
- ISO 9001