CSV - Computer System Validation
3 weeks ago
Role: CSV - Computer System Validation
Job Location: Bangalore
Exp Required: 5-10 years
· Experience in Quality and Compliance with hands-on computer system validation experience
· Perform assessments of computer systems and processes for Life Sciences clients (compliance with internal procedures, leading practices, and regulatory requirements)
· Create / review CSV deliverables like user requirements, system specifications, Validation Plan, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design Specs, and validation summary reports
· Provide guidance and oversight of validation activities for projects involving GxP relevant computer systems
· Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle
· Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation
· Review and approved computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables
· Experience in training validation resources will be an added advantage
· Experience in performing assessments based on 21 CFR Part 11 and Annexure 11 requirements.
· Experience in SAP
if interested, please share your resume at shikha@tdnewton.com
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