*Hi All,*
*Please share the profile at arv...@idctechnologies.com <arv...@idctechnologies.com> * *Position: LIMS CSV consultant profiles* *Location: Naples, Florida* *Duration: 6 Months* Main Objective: Support computer system validation activities. Work Location: Naples, Florida, US Experience: 8+ Years Essential Duties and Responsibilities: • Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in validation. • Coordinate, assist and document validation activities; preparation/approval of protocols and reports. • Draft, review and approve local validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation. Examples include SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls. • Prepare, assist, or participate in system design, specification development, and design review. • Perform systems FDA validation for QAD and customizations. • Perform revalidation and change control validation related activities. • Ability to apply complex system validation principles to work assignments. • Must be able to function independently, play a leadership role within a cross-functional team and address a variety of moderate to complex problems. • Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change. • Provide training to colleagues and contractors on our approach to systems implementation and validation SOP’s. • Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering, business owners. • Develop and maintain Validation SOPs, forms, documentation and files. • Coordinate meetings, document issues, action items, meeting notes, do appropriate follow up related to CSV projects. Recommend enhancements to project specs • Coordinates fulfillment of all requirements for systems audits • Project Management and mentorship of junior-level analysts *Thanks and Regards* *Arvind Nagar* *Email- **arv...@idctechnologies.com* <arv...@idctechnologies.com> *Direct-408-457-9381 Ext-4008 !! Gtalk- arvindnagar.777 !! Yahoo- * *arvindnagar951* -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To unsubscribe from this group and stop receiving emails from it, send an email to us_itgroups+unsubscr...@googlegroups.com. To post to this group, send email to us_itgroups@googlegroups.com. Visit this group at http://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/d/optout.
