Job Description:-
CSV, Computer System Validation, Tools validation, Quality Management System, 21 CFR 820, ISO 13485
Roles and Responsibilities:-
In addition to validation and regulation experience, the resource should have the following experience.
3 to 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