We are looking for a *Validation Test Manager with Life Sciences Domain &
OPSM (Oracle Pedigree Serialization Manager)*.



Location – Foster city CA

*Key responsibilities: *



Need candidates with any one of the application skills which we mentioned
below.



*Experience/practical understanding of OPSM (Oracle Pedigree Serialization
Manager) testing.*

*This can have skills on serialization – could be knowledge on Axway /
Anteras or Systech*

*·         Good functional knowledge on Oracle Inventory, and Manufacturing
modules especially of Oracle Process Manufacturing*

·         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





·         9 - 12 years of Experience in Life Sciences, Computer System
Validation

·         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

•             Disaster Recovery Qualification

•             Qualification and Commission

•             Validation coverage in IQ, OQ and PQ

•             Deviation management process

•             CAPA

•             Validation Summary Reports

·         Knowledge on Infrastructure IQ & qualification

-- 

*Regards,*


*Hartinder Kaur*

*Technical Recruiter*
------------------------------

*E: **[email protected]
<[email protected]>*

LinkedIn:https://in.linkedin.com/in/hartinder-tracy-1412994a

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