Keywords – CSV, Computer System Validation, Tools validation, Quality Management System, 21 CFR 820, ISO 13485 , Acquisition and mergers
In addition to validation and regulation experience, the resource should have the following experience:
Roles and Responsibilities
- Minimum 7 years' Experience in the Validating IT software systems like Quality Management System in Life Sciences industry
- Experience in FDA and/or Global regulated environment with good understanding of GxP standards like CFR 820 and Risk based validation.
- Experience in validating Global Risk and Compliance modules
- Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality
- Knowledge of FDA guidance's and industry standards
- 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 related to System data Archival process
- Hands-on experience in software life-cycle management in System data archival process
Ability to provide Validation guidance, timely reviews, and escalations to Project teams