Vacancy expired!
- Argus , TrackWise and other R&D GxP systems
- Documentum or any document management system such as EDMS
- MicroFocus ALM (Test Management Tool)
- 10+ years of Experience in Life Sciences, Computer System Validation
- Pharmacovigilance, R&D GxP systems knowledge, Medical Device knowledge is plus
- Must possess hands on experience and understanding of
- GAMP 5 Risk Based Validation
- Functional Risk Assessment
- GXP Assessment
- 21 CFR Part 11 Assessment
- Data Migration Qualification
- Qualification and De-Commission
- Validation coverage in IQ, OQ and PQ
- Deviation management process
- CAPA
- Validation Summary Reports
- Knowledge on Infrastructure IQ & qualification
- Leading and managing testing and validation activities in synchronization with project scope, schedule and objective
- 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/ clients
Vacancy expired!