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Robert Ciociola posted a job:

"Looking for an Excel Spreadsheet/Remediation Validation Resources - in Lancaster, PA Excel Spreadsheet/Remediation Validation Resources - Lancaster, PA Contract-8-10 Month Send resumes to: bciociola@covexllc.com Responsibilities: The ideal candidate will need to understand computer system validation for a broad spectrum of pharmaceutical application, ideally with in-depth knowledge on how to develop excel spreadsheet validation packages in an FDA Regulated environment. The candidate must have: • Five years of expertise in preparing, executing and defending Remediation Plans, Change Controls, Requirements, Design Specs, Traceability Matrices, IQ, OQ and PQ protocols and summary reports for spreadsheets is a must. • Five years of additional computer system validation project work developing or reviewing documents in areas of automation, laboratory, and global systems following system life-cycle methodology. Project Scope Conduct the following contract services within established timeframe and in accordance with cGMPs and applicable company Quality Standards, policies and procedures. Provide guidance, mentoring, training in creating validation packages and review of the above deliverables for spreadsheets. Providing guidance and mentoring in resolution of testing incidents and deviations. Review of final qualification reports and traceability matrices. Completing work consistent with company's quality standards, policies and procedures. Regular and effective communication of project status to Project Management http://bull.hn/l/9145a3a10a9565509efb25e9da142dff/"

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