Experience in validating systems and experienced in CSV activities in GxP related applications like SAP, Argus, Veeva Systems. Perform review for GxP systems to ensure compliance with regulatory requirements as per the customer SOPs. Expertise in end-to-end validation of GxP applications and ability to perform document process compliance analysis. Adept with Agile and Waterfall methodology.
Requirement Specifications, Functional Specifications, User Stories, Acceptance Criteria, and ensuring completeness of test scripts with traceability. Ensures Risk Assessment is completed for all the requirements...