CSV Consultant (Day 1 Onsite)

Keywords - CSV, Computer System Validation, End to end validation, CSA, Computer System Assurance

• Background and experience in AGILE SAFE methodology.

• Experience in the Pharmaceutical, biotechnology, or medical device industry

• 3 to 7 years' experience in Computer System Validation

• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.

• Knowledge of FDA guidance's and industry standards (i.e., GAMP)

• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports

• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.

• Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.

• Ability to provide Validation guidance, timely reviews, and escalations to TQ management.

• Perform Operational Change request in-process review for all Operational Changes

• Contribute, track and drive IT deviations / exceptions / gaps to closure

• Post-event analysis of quality of Incident/Problem tickets to provide assurance that the required controls are adhered to, on a periodic basis

• Prepare application for audits / assessments and provide support during audits / assessments

• Ensure applicable Controls are adhered to in the Application. Request for gaps as appropriate

• Involved during project transition, as quality manager by reviewing the User Requirements, Functional Risk Assessment, Validation Plan, Testing deliverables (IQ, OQ and PQ), Validation report.

• Always perform life cycle documents with respect to GDP

• Ensure that the validated state of the system is maintained

• Handling the Deviation, RCA, CAPA, Change Management, Incident Management, Problem Management, Periodic Controls as per client policies/procedures

#INDW3