Supports and collaborates with the project team for validation efforts right from inception, design build, test and implementation.
Investigate/troubleshoot validation discrepancies for systems and/or performance processes.
Support validation activities – IQ/OP/PQ.
Create change controls and provide assistance in determining root cause for non-conforming events and evaluate CAPAs for effectiveness.
Ensures required processes and procedures are followed to support validation programs and are in compliance with regulations.
Co-operates with all departments through open, candid communication and collaboration.
Knowledge of statistical analysis to assess control and manage risks of product quality and determine the responsibility for products or materials that do not meet required standards and specifications.