Needed profile with at-lease 10 years of experience !! My name is *Aakash Mishra* working with *Golden Resource* as an IT Recruiter. Golden Resources Inc is an IT Consulting, Staffing and Solutions company headquartered at Cincinnati Ohio with over 15years of track record of providing excellent services to our precious clients.
The reason for my email is to let you know about a wonderful job opportunity of *CSV Validation Lead for Longterm Contract in Northbrook, IL.* *Title: CSV Validation Lead* *Location : Northbrook, IL* *Duration: Longterm* *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 system or application. The Validation Lead works 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.. [image: Golden Resource, Inc] *Aakash Mishra * US IT Recruiter Direct : 513-823-2012 T: 513-342-6290 Ext 106 | F: (513) 823-2037 E: amis...@goldenresource.com W: www.goldenresource.com *“Building Bridges between Business and Technology.”* [image: http://static2.exclaimer.com/icon-facebook_28x28.jpg] <https://www.facebook.com/aakash.a.mishra?fref=ts&ref=br_tf>[image: http://static2.exclaimer.com/icon-twitter_28x28.jpg] <https://twitter.com/Aakash2390>[image: http://static2.exclaimer.com/icon-googleplus_28x28.jpg] <https://plus.google.com/109760864378464907691/posts/p/pub>[image: http://static2.exclaimer.com/icon-linkedin_28x28.jpg] <http://www.exclaimer.com/email-signature-creator/in.linkedin.com/pub/aakash-mishra/a1/646/a74/> [image: http://geekwhisperin.files.wordpress.com/2011/08/please-consider.png] The company accepts no liability for the content of this email, or for the consequences of any actions taken on the basis of the information provided, unless that information is subsequently confirmed in writing. If you are not the intended recipient you are notified that disclosing, copying, distributing or taking any action in reliance on the contents of this information is strictly prohibited. -- 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.
