CSV - Computer System Validation

2 weeks ago


Bengaluru, India MNC Group Full time
Role:

CSV - Computer System ValidationJob Location: BangaloreExp 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



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