Hi Folks,
Please find the below demand. Please submit qualified candidates asap Client - Cognizant Need Passport number for submission Please share resume at Varun.j@net2source (DOT) com *Position : Computer System Validation Analyst/Engineer* *Location : Chicago, IL/ Remote* *Job Description :* Domain skill- Pharmaceuticals/Biotech or Regulatory Mirror - LIMS or MES or QMS in regulatory industries - Experience in drafting and/or reviewing computer validation deliverables such as Validation Plan Requirements Specifications Risk assessments IQ OQ PQ/UAT - Configuration and Design Specification Traceability Matrix Migration Plan and Summary Reports. - Reviews and assists System and Business owner to draft software user specifications and regulatory requirements. - Executes validation and qualification protocols test scripts and summary reports per applicable SOP’s and assures that acceptance criteria related to validation and qualification protocols are met. - Assist in the creation of training materials such as work instructions admin guides and user manuals. - Assist in developing validation and testing strategies for computer system projects. - Perform or support system testing test script execution (internal or vendor-provided) test error documentation and resolution and test script documentation and archiving. - Experience in change management process including performing impact assessments to determine impact of changes to the Validation Status using appropriate change control procedures. - Experience in drafting and/or reviewing validation and change control protocols documents and reports. - Review and remediate executed test scripts for GDP errors and omissions. - Experience in drafting and/or reviewing testing exception reports. *Qualifications and Minimum Requirements * 1. 5 + years IT Quality / Validation experience in computerized system validation within a regulated environment. 2. Knowledge of GxP and ERES (21CFR Part 11 and Annex 11) regulations and guidelines 3. Working knowledge of the IT system development life cycle and software quality assurance in a regulated environment. 4. Knowledge of IT methodologies including GAMPS and ITIL Experience with risk analysis and risk management practices and tools. 5. Good communication skills both verbal and written 6. 6. Knowledge of general software database concepts and data integrity knowledge of infrastructure technology and platforms. 7. The ability to work both independently and with teams 8. Experience with LabVantage LIMS/MES or Veeva QMS is preferred 9. Experience with the below systems is preferred: a. Document management software (Veeva QualityDocs etc.) b. IT change management software (ServiceNow etc.) c. Learning Management software (ComplianceWire etc.) d. Regulatory Information Management System (Veeva RIMS etc.) e. Inventory Management System f. Manufacturing Execution System 10. Bachelor’s Degree in information technology Computer Science and/or any other closely related field is highly preferred. Regards, *Varun Jain* *Senior Recruiter* *Net2Source Inc.* *Email: *Varun.j (@) net2source.com <varu...@net2source.com> -- You received this message because you are subscribed to the Google Groups "Android Discuss" group. To unsubscribe from this group and stop receiving emails from it, send an email to android-discuss+unsubscr...@googlegroups.com. To view this discussion on the web visit https://groups.google.com/d/msgid/android-discuss/CAHQm1RNZ5nsDMiWDhOgiyZ5V_TST_gaKrrQLZfasOAgL3ndL6Q%40mail.gmail.com.