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Computer System Validation (CSV)

Company Name:
GLOBAL PHARMATEK, LLC
Greetings!
Below is the job description for the Computer System Validation position. Please let me know if youre interested.
Title: Computer System Validation (CSV)
Location: Spring House, PA
Duration: 12 plus Months Contract
If you are interested in this job opportunity please send across your resume to .
TECHNICAL SKILLS:
Requires thorough understanding of System Development Life Cycles for FDA regulated applications.
Must be experienced in developing Computer System Validation deliverables for FDA-regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts (IQ, OQ, PQ), Traceability Matrix, and Validation Reports.
Requires thorough knowledge of US CFR 21 Part 11 regulations.
Experienced with high volume application testing environment.
Experience with automated Software Testing tools is a plus.
Familiarity with QA Familiarity with a Corrective and Preventative Action program is a plus.
NON-TECHNICAL:
Ability to work within a Project Team setting. Ability to guide a project team through the validation process.
Experienced in working within an FDA regulated environment for the Pharmaceutical and/or Medical Device industries.
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.
Manage validation Project Plan. Responsible for tracking, coordination, and project planning of Computer System Validation activities.
Methodology/Certification: Bachelor Degree in Chemistry, Mathematics, Engineering or Computer Science.
Advanced course work in technical systems or continued education in technical disciplines is a plus.

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