Computer System Validation Lead

Job Description

Candidate needs to work from our Client site Based in Foster City CA.

• 21 CFR Part 210 / 211
• GAMP 5 Risk-Based validation / ICH Q9 hands-on implementation knowledge
• Manufacturing, Distribution process and procedure
• Experience in managing large implementations / upgrade project
• Strong knowledge on change management procedure & process; Should have handled more than 20+ change requests
• Hands-on knowledge of Deviation and CAPA Management
• Leading and managing testing and validation activities in synchronization with project scope, schedule, and objective
• Must possess formal training / certification on Testing & Validation
• Excellent communication skills
• Excellent technical writing skills
• Should be able to work independently with minimum supervision

Should have worked in cross-functional environments and comfortable to liaison with business

Qualifications

Below applications Experience Must.