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Title: Business Analyst / Validation Specialist / Prod Support Role Location: PA Duration: 5 months initially, with possible extension RESPONSIBILITIES: - Review of Features, Identification of Impacts to current functionality, identification of deliverables requiring revision - Creation of Change Control records, Perform Revision of lifecycle deliverables (URS/FS/SDS), - Identify regression testing requirements, Identify focused testing requirements (Challenge testing if high risk) - Create test scripts (IQ/OQ/PQ), perform dry run, work with end users and IT staff to plan execution. Participate in / oversee execution of test scripts. - Plan implementation of items along with IT staff (may involve security changes / SOP revisions / Work Instruction revisions / Training Material creation) - Assist with Production Support Issues Validation Scope: - New feature / module validation, including gap analysis of existing documentation. - Upcoming Release Validation - Planning/Execution of Validation / Data Migration requirements - May participate in all aspects of validation deliverables QUALIFICATIONS: - MOST CRITICAL SKILLS NEEDED ARE: Computer System Validation and Business Analysis in a regulated pharmaceutical environment. - Candidate should have at least 5 years experience as a Business Analyst managing system change / supporting implementation & maintenance of validated systems. - This position will be responsible for participating on the team as a Business Analyst and understand how to execute technical concepts, not just how to document them. - This individual will also assist with the development of the strategy for validation, development of all required SDLC deliverables and reports for a series of Change Controls and a large System Change / Data Migration effort for a learning management system. - The candidate must have experience in the pharmaceutical industry and experience in computer system validation. - Knowledge and experience working with GXPs protocols is preferred. - Experience developing Validation Plan and executing validation strategy. - In depth experience working in a Pharmaceutical SDLC processes. Experience writing all SDLC document (IQ, OQ, PQ and SDLC Documentation). - Assist in development of migration strategy (sampling / verification) and test approach. - Managing the execution of Validation Deliverables & UAT. - Development of Validation Reports. - Managing & tracking test deviations. Directs the resolution of deviations and failures. - Strong understanding of 21 CFR Part 11. - Experience trouble shooting and end support customer service. The following Experience, while not mandatory, are a plus for a candidate: - Use of HP Quality Center for management of requirements / test script authoring / execution - Experience with a Learning Management System (LMS), preferably UL EduNeering’s ComplianceWire (formerly Kaplan EduNeering) - Help Desk Support -- You received this message because you are subscribed to the Google Groups "Companies Looking for IT Out Staffing & Recruitment" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/arunsinh?hl=en. For more options, visit https://groups.google.com/groups/opt_out.
