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*Title: QA CSV Validation/Pharma Quality & Compliance (10 Resource Needed)* *Location: Vernon Hills, Illinois* *Duration: 6 + Months* *The other possible location will be Westlake Village, CA for these roles* Need Pharma System Validation resources. Typically testers in the pharma domain. *Job Description:* Participate in the development of strategic compliance deliverables to support applicable regulations and internal policies and to ensure that the systems to be developed adhere to corporate process methodology. Drive the understanding and adoption of Quality and Compliance standards. Ensure Quality & Compliance requirements are considered in any New Project initiative or Change request. Assure that the compliance deliverables are updated and kept current with all applicable changes. Work with IT and business teams to drive/maintain/create Quality program. Align the development methodology with Compliance plans, policies and procedures. Effectively manage ongoing change control process (interface to IT support, impact analysis, release management, Data Management, testing, Audits etc.). Build strong relationships with the Business owners. *Qualifications* • 5 - 7 years’ experience in Pharma Quality & Compliance. • Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards. • Experience in Computer system validation and knowledge of GAMP 5 • Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/validation reports. • Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. • Experience in Software Development Lifecycle (SDLC). • Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. • Experience in Change Control. • Experience on various FDA standards (21 CFR Part 11, 210, 211, 820) • Experience is creation of SOPs. • Knowledge of FDA guidance’s and industry standards (i.e., GAMP5) • Hands on experience in HP Quality Center and QTP. • Strong verbal and written communication skills. • Able to work as a team player, lead a team or accomplish tasks without supervision. • Ability to work with remote teams and support several changes/projects simultaneously. • Flexibility to work with an onshore/offshore model. *General* • A Bachelors’ degree • Excellent Communication Skills • Excellent Stakeholder Management Skills *Thanks* *Chris* ch...@appnetglobal.com -- You received this message because you are subscribed to the Google Groups "Business_Intelligence" group. To unsubscribe from this group and stop receiving emails from it, send an email to business_intelligence+unsubscr...@googlegroups.com. To post to this group, send email to business_intelligence@googlegroups.com. Visit this group at http://groups.google.com/group/business_intelligence. For more options, visit https://groups.google.com/d/optout.
