About the job
- Conduct regular evaluations of equipment to ensure optimal performance.
- Oversee the routine assessment of controlled temperature chambers.
- Manage periodic evaluations of computerized systems, including the identification of systems requiring review.
- Prepare and report on the Annual Product Review for commercial equipment.
- Take ownership of the Validation Master Plan, ensuring comprehensive documentation and strategy.
- Lead investigations into deviations and support Corrective and Preventive Actions (CAPA) associated with Validation Maintenance concerns.
- Perform Validation Change Control assessments to maintain compliance.
- Lead, author, and facilitate Quality Risk Assessments for Equipment and Automated Systems (QRAES).
- Track performance metrics and generate reporting for continuous improvement.
- Execute qualification and validation processes for new or modified equipment.

