*Job Title : Validation Consultant*
*Location: Jacksonville FL*
*Duration: 6+ months*

--------------------------------------------------------------------------------------------------------------------
 *At least 7 years experience*

 Job Description:
Enforce validation and quality requirements and Good Documentation
Practices for validation documentation.  Document and execute test cases
against requirements and design documents, to validate the results.  Must
be flexible to meet aggressive deadlines. Work with project team to
communicate and understand validation requirements in a Quality &
Compliance perspective. Report to the Project Lead, and provide status
updates.

Technical: At least 7 years experience with software systems validation and
testing. Requires thorough understanding of System Development Life Cycles
for FDA regulated applications. Excellent understanding of test execution
and typical defect management practices in an FDA-regulated environment.
 Experienced with high volume application testing environment.  Requires
thorough knowledge of US CFR 21 Part 11 regulations. Requires working
knowledge of at least one of the following: US CFR 200 or 300 or 800
series.  Knowledge of manufacturing processes a big plus. Familiarity with
QA Systems is a plus.  Familiarity with a Corrective and Preventative
Action program is a plus.  Good knowledge of requirements risk assessment
and their impact on the testing effort.

Non-Technical: Ability to work within a Project Team setting.  Ability to
guide a project team through the validation process.  Track, schedule and
manage validation issues to ensure commitment dates are met.  Jointly
develop, communicates plan with project team.  Insure timely flow of
information with project team.

Methodology/Certification: Bachelor Degree in Sciences, Mathematics,
Engineering or Computer Sciences.  Advanced course work in technical
systems or continued education in technical disciplines is a plus.

------------------------------------------------------------------------------------------------------------------
Thanks and Regards,
Raj Paul
Sr. Technical Recruiter
Phone : 248-918-2510 EXT 1002
Email: [email protected]
IM Gtalk & Skype : rajpaul232
VipraInfoSystems |http://www.viprainfosystems.com
West Big Beaver Rd. Suite 200,Troy, MI 48084 USA

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