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*Role : CSV Lead with Trackwise Experience* *Location : Northbrook, IL* *JOB DESCRIPTION - Computer System Validation (CSV) Lead* This position is responsible for leading and performing activities in support of the validation and compliance of a *TrackWise (TrackWise v 8.7.12 application)*.The Validation Leadworks closely with Client stakeholders and other cross functional teams to ensure smooth execution of the project and schedule adherence. This position is responsible for providing subject matter expertise and client solution in the field of *Pharma/Med Devices Computer System Validation*. *DUTIES/RESPONSIBILITIES* 1. Leads the Computer Validation activities within a project with high complexity. 2. Responsible for creating, managing, and/or maintaining the documents required for the development and validation of the computerized system. a) Create and review all validation documents in the project. § Authors Validation Plan, Training Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Test Incidents, Trace Matrix, and Validation report. § Reviews Functional Specifications, Design Specifications, User Manuals, System Procedures, System Description and Training records. b) Creates or contributes to the Supplier Audit Report. c) Contributes to or gathers CSV metrics for reporting purposes. 3. Oversight of protocol execution - Manages the overall protocol execution process, including resource management, scheduling/timeline management, incident management, and status reporting. 4. Develop internal CSV training material. 5. Lead CSV effectiveness and improvement initiatives. 6. Lead CSV knowledge development. 7. Co-ordinate between various sites for validation of Global Labeling Platform 8. Devise Master Validation Plan in collaboration with all the responsible project teams including documentation of the scope, detailed time estimation, work schedule and the documentation of assumptions and risks 9. Work with respective teams to determine regulatory requirements, validation requirements, business & functional risks and ensure documentation of the same 10. Design templates and checklists to monitor the progress of the project and ensure that all the required information is captured and documented 11. Responsible for URS, FRS, Risk Assessment, IQ/OQ/PQ Testing and Validation Summary Reports. *EDUCATION and Experience* - Bachelor’s degree in Computer Science with 8-10 years of experience in validating software systems in an FDA, GxP regulated environment. · Experience in Life sciences or Pharmaceuticals processes / projects especially in Product Content / Labeling is preferable. · In depth knowledge of 21 CFR Part 11, 21 CFR Part 820 and other GxP (GMP, GCP, GLP, GDP) regulations Regards *Ajit Rathore* *InfiCare **Technologies*| 22375 Broderick Drive #225 Dulles VA 20166 | 703-945-1834 Direct | *aj...@inficaretech.com* <aj...@inficaretech.com> *www.infiCareTech.com* <http://www.inficaretech.com/> Servicing our clients since 2001 MBE/ DBE Certified in VA, MD, PA, NJ, NC, CA IT Services * Application Development * Mobility Solutions -- You received this message because you are subscribed to the Google Groups "Oracle-Projects" group. To unsubscribe from this group and stop receiving emails from it, send an email to oracle-projects+unsubscr...@googlegroups.com. To post to this group, send email to oracle-projects@googlegroups.com. Visit this group at https://groups.google.com/group/oracle-projects. For more options, visit https://groups.google.com/d/optout.
