Hi,

Greetings from American IT Resource Group Inc.!

I would like to touch-base you regarding multiple job opportunities with
our client, appreciate if you could go through below job detail and let me
know your thoughts as soon as possible.

 *Reply only to vasa...@aitrg.com <vasa...@aitrg.com>*



*Role: Trackwise Validation Test Lead*

Location: Foster City, CA

Duration: Long term Contract



*Skills: Validation Test Lead, CSV, 21 CFR part 11, Trackwise*



*Job Description:*

Ø  7-10 years of Experience in Life Sciences, Computer System Validation
and Testing

Ø  Must possess hands-on experience in Trackwise

Ø  Good understanding of

o   FDA regulations, 21 CFR Part 11, GxP requirements along with knowledge
of GAMP, GDP

o   CSV (Computer System Validation) SOPs, SDLC and testing processes

o   LS COTS products (Trackwise, Documentum, Veeva, LIMS, LMS, CTMS etc)

Ø  Experience in

o   Creating/Reviewing Validation documents across the Validation Life
Cycle like Validation Plan, Protocols (IQ,OQ,PQ), Incident Report, RTM,
Validation Summary Report

o   GxP Regulatory Assessment, Risk Assessment, Validation Planning &
Validation Reporting

o   Working with Test Management tools (HP ALM/Jira/Bugzilla)

o   Performing estimations for Validation and Testing activities

o   Leading and managing testing and validation activities in
synchronization with project scope, schedule and objective

§  Daily/Weekly status reporting

§  Risk Management & Timely Communication

Ø  Must possess formal training/certification on Testing & Validation

Ø  Excellent communication skills

Ø  Should be able to work independently with minimum supervision

Ø  Should have worked in cross-functional environments and comfortable to
liaison with business


Thanks & Regards,



*Vasanth** - **Technical Recruiter*

*American IT Resource Group, Inc.*

1111, Plaza Dr., Suite 640, Schaumburg, IL - 60173

Desk: 312-561-4349 || Email: vasa...@aitrg.com

Skype: vasanth.aitrg <vasanth.ai...@gmail.com> || Gtalk: vasanth.aitrg
<vasanth.ai...@gmail.com>

www.aitrg.com



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