Senior Computer System Validation (CSV) / CSA Lead

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

• 20–30 years in pharma & medical sales
• SOP writing
• SCADA
• ERP
• ISO 9001
• B.Tech or B.E. or B.Sc or BCA