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Robert Ciociola posted a job:

"Looking for a CSV Lead- 338 in Fort Washington, PA CSV Lead- Fort Washington, PA 338 Contract-24 months Send resumes to: bciociola@covexllc.com Location/Division Job Description The Lead, Computer System Validation is responsible for ensuring that GxP regulated computerized and Automation systems are in full compliance with regulatory requirements, company policies and procedures. Provide compliance leadership, direction and oversight to project teams in Computer System Validation. This individual is responsible for the quality oversight of GxP regulated computerized (e.g. manufacturing plant systems, laboratory systems and enterprise applications). This individual will support leadership and compliance support activities include, but are not limited to SOP revisions, documentation review and approval (including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports). The candidate will manage the release of regulated systems for GxP production use. This individual will support the 24/7 operations of the manufacturing plant, resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 820, 11 and Annex 13). In addition, this individual will lead and participate in project teams and may participate in regulatory inspections (e.g. FDA.) Assignment duration of the Lead Computer System Validation, CD to last through December 2014. Education: A minimum of a Bachelors degree and 6 years of related industry experience OR an advanced degree with 5 or more years of related industry experience is required. A focused degree in a technical, scientific or related field is preferred Experience/ Technical Competencies: A minimum of 6 years of business experience is required. A minimum of 3 years of experience in CSV system development life cycle is required. Job Knowledge/Skillsets: Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required. Strong knowledge of laboratory systems is preferred. Six (6) positions will be based in Fort Washington, PA and one (1) will be based in Las Piedras and may require up to 10% travel. Travel: There is up to 10% travel anticipated for this role. Contract: Through 12/31/2014 http://bull.hn/l/V4Y9/"

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