Responsible for coordinating and executing process, equipment, materials and software validations, and assuring validations are in compliance with the quality and regulatory requirements.
Supervise validation technicians.
Prepare validation protocols (IQ/OQ/PQ/MVP) and reports and coordinate all validation activities through constant communication with affected departments and personnel.
Negotiate start and completion dates for validation efforts, required equipment and supplies.
Follow validation testing strategy and recommend process and product improvements.
Support, organize and participate in technical design reviews, peer reviews, team meetings, and process audits.
Ensure closure of process validation issues.
Train operational users as required.
Manage the tasks and activities for direct reports and evaluate their performance.