Manage validation activities of cross-functional teams to ensure validation effort is executed to plan and properly documented in the appropriate validation documents.
Support resolution and documentation of protocol and test discrepancies/deviations.
Provide training and support for user acceptance testing.
Monitor and track progress of test execution and deviation management activities.
Perform initial quality review of execution results.
Maintain computerized system validation documentation.
Requirements:
Bachelor’s degree in life sciences, computer sciences, or a related field or an equivalent combination of experience and education
A minimum of 4 years in direct hands-on experience validating GxP Computerized Systems
Advanced knowledge of GxP regulations and approaches to System Life Cycles (SLC) and GAM
Experience validating SAAS systems
Experience in GxP regulated industry
Generation and Management of IT Computerized System Validation Deliverables