Duties:
Lead end-to-end validation projects, ensuring timely delivery, compliance, and quality outcomes.
Develop, review, and execute validation protocols, procedures, and documentation in accordance with regulatory and industry standards.
Plan, coordinate, and manage validation activities using project management tools (e.g. Gantt charts).
Prepare and maintain SOPs related to equipment and facility validation.
Participate in project meetings, workshops, staff training, and validation-related documentation activities.
Evaluate and recommend equipment, systems, and vendors based on user requirements and project needs.
Monitor project progress, provide updates, and manage stakeholder communications.
Drive process improvement initiatives to enhance operational efficiency and productivity.
Support client audits and act as a Subject Matter Expert (SME) for validation-related activities.
Conduct investigations, perform root cause analysis (e.g. 6M, Fishbone/Ishi...