Provide Quality oversight and approval regarding qualification and validation in compliance with regulatory regulations/guidelines. Administer and control the Validation program which includes equipment, processes, utilities, facilities, computers, cleaning procedures, laboratory equipment, and analytical methods to demonstrate that product will perform consistently as intended.

Responsibilities

• Responsible for the audit, pre-approval and post-approval of all process validations protocols, cleaning protocols and analytical test method protocol as the QA signature.
• Maintain and control the Validation Change Control Program for the validated/qualified systems and the Validation Management System (VMS).
• Review and approval of Validation Master Plan.
• Create validation documents, such as Soltraqs Change Plans, Validation Plans, Technical Reports and Position Papers.
• SME on process validation aspects (process changes, cleaning validation, dust controls, hold times, test method validation, analytical instrumentation qualification).
• Conduct training related to Validation, Qualification and Management of change.
• Responsible for continuous improvement aspect of process validation by developing and supporting projects to streamline process from unnecessary tasks and paperwork.
• Provide leadership and guidance for validation related CAPA activities.
• Member of the Quality Risk Management and participate in development of FMEAs and Risk Control Plans as validation SME.
• Administer the Validation Review Board.