Computer System Validation Lead

Computer System Validation Lead

iTvorks provides answers to enterprises in a wide range of business sectors such as medical, real estate, and finance among others. We have reliably helped many organizations see their visions come to life by entirely managing the lifecycles of their products, infrastructure and applications.

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.

• SAP
• Oracle EBS
• LIMS
• VEEVA or Salesforce

Additional Information

All your information will be kept confidential according to EEO guidelines.