-- 
Hi Folks,

Hope you are doing well.

Please do send resume only to "*[email protected]
<[email protected]>*"
-----------------------------------------------------------------------------------------------------------------------

*Job Title: Validation Lead *

*Location: Foster City, CA*

*Duration: 12+ months*



*Skills: *



·         7+ Years of overall experience with Validation Testing,
experience in Pharma Domain. Experience in Software validation and
compliance activities in Pharma (GMP) environment. Experience in working
with GxP applications. Experience in creation/maintenance & implementation
of SOPs

·         Experience in the use of HP Quality Center and similar tools to
manage software testing and requirements. Worked in cGMP, 21 CFR Part11 and
GAMP 5 environment

·         Hands on authoring/ review/ approval of computer system
validation deliverables, inclusive of requirements gathering.  Functional
specification, test/validation plans, protocols, test scripts / cases,
traceability matrix and summaries

·         Experience in Information Technology, hands on computer system
validation activities. Worked in cGMP, 21 CFR Part11 and GAMP 5
environment. Hands on authoring/ review/ approval of computer system
validation deliverables, inclusive of requirements gathering.  Functional
specification, test/validation plans, protocols, test scripts / cases,
traceability matrix and summaries. Experience in the pharmaceutical or
biotech industries supporting IT initiatives

·         Demonstrated skills for independently guiding quality and
compliance activities during system application design, development and
deployment in the pharma industry.
·         Experience with risk based approaches to validation (GAMP 5)


*Regards *

*Vikas Dussa*

*408-457-9381 Extn 4037*
*[email protected] <[email protected]>*

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