SQAFYI - Software QA Resource - FYI

US-FL-Naples: Software Validation Manager

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Date: 18-Jan-2013

Software Validation Manager

•Lead validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering, business owners. •Lead development and maintenance of Validation SOPs, forms, documentation and files. •Lead development and review of Application Design Specifications, Test and Acceptance Plans •Coordinate fulfillment of all requirements for systems audits. Will be lead IT person for FDA, financial, and similar audits. •Project Management and stewardship of overall software validation functions •Assist in overall business applications strategy

•Bachelor’s Degree required; advanced degree preferred •At least 10 years overall experience in an FDA regulated environment with a focus on software validation •At least 7 years management or direct supervision experience •Experience in a medical device manufacturing environment preferred •Strong Project Management Experience required •Experience leading computer software validation for a significant full-cycle manufacturing or quality system implementation

Knowledge and Skill Requirements/Specialized Courses and/or Training: •Excellent communication skills and customer service orientation •Familiarity with GMP and other approaches to System Development Life Cycles (SDLC), CAPA. •Computer knowledge of 21 CFR Part 11, CFR 820Excellent communication skills and customer service orientation •Training, certifications, and/or coursework in APICS, PMP, Six Sigma or ITIL strongly preferred •Must have thorough understanding of FDA regulations and computer validation guidance documents •Proficiency with HP Quality Center a plus

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Thank you,
Team SQAFYI - Software QA Resource FYI

US-FL-Naples: Software Validation Manager