10+ ONLY - Validation Lead @ Foster City - CA

[azhar uddin]

Hi Professionals,

Role : Validation Lead 

Location : Foster City - CA

Visa :  NO H1 Transfers

Job Roles / Responsibilities:       

Must Have Skills : 9 - 12 years of Experience in Life Sciences, Computer S

• 9 - 12 years of Experience in Life Sciences, Computer System Validation (CSV)
• Must possess hands on experience and understanding of
o GAMP 5 Risk Based Validation
o Functional Risk Assessment
o GXP Assessment
o 21 CFR Part 11 Assessment
o Data Migration Qualification
o Disaster Recovery Qualification
o Qualification and Commission
o Validation coverage in IQ, OQ and PQ
o Deviation management process
o CAPA
o Validation Summary Reports
• Knowledge on Infrastructure IQ & qualification
• 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
• Must have experience of working in an onsite-offshore model

Thanks & Regards

Mohd Azhar uddin

Tel: 703-831-8282 Ext. 2526,(M) (315) 543-4232

Email: m.a...@canopyone.com