Computer System Validation III at Raritan

Job Description

Description

Requires substantial experience with (System Development Life Cycles) using Agile methodology 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. Requires working knowledge of at least one of the following: US CFR 200 or 300 or 800 series. Experienced with high volume application testing environment. Requires technical competence with n-tier application development and cloud-hosted applications. Experience with automated Software Testing tools is a plus. Familiarity with QA Auditing is a plus. Familiarity with a Corrective and Preventative Action program is a plus. Experience with medical device validation/qualification is a big plus.
Non-Technical: Experienced in working within an FDA regulated environment for the Pharmaceutical and/or Medical Device industries. Ability to work within an agile project team setting. Ability to work in a rapid deployment group. Ability to self-direct and follow up with all compliance team members to ensure timely deliverable of project documentation. 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.
Experience: 5-7 years Pharmaceutical and/or Medical Device industries validation, 2-3 yearsSDLC

Years of experience: 5-7 years pharma validation, 2-3 years SDLC

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Job Requirements

 
Country: USA, State: New Jersey, City: Raritan, Company: KellyMitchell.