Validation & Qualification Supervisor

Job Purpose

This position is responsible for managing multiple projects to provide documented validation of equipment, control systems, CGMP utilities and manufacturing processes, establishing philosophy, structure and scope in compliance with regulatory requirements through Validation Master Plans, policy and operating standards

RESPONSIBILITIES AND TASKS: 

• Initiate and execute validation studies throughout the facility.
• Interact with all levels of management and staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, support and approval for identified validation projects.
• Plan, schedule and organize validation projects for new and existing areas, including manufacturing processes, plant systems, cleaning and equipment.
• Identify necessary internal and external resources for completion of validation projects and secure the necessary support (Production, QC, and QA, outside contractors).
• Interface extensively with the QC/QA, Production and engineering departments to identify projects and problems requiring validation support.
• Plan and manage priorities to ensure critical projects meet required deadlines.
• Develop and implement all necessary Standard Operating Procedures for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ) and requalification of critical systems, utilities and production processes.
• prepare the protocols for process validation, hold time study, campaign length cleaning validation, IQ/OQ and performance qualification.
• Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories and outside contractors providing leadership, training and guidance.
• Follow up overall qualification/validation activities include (HVAC, thermal mapping, machine qualification, laboratory instrument qualification, etc….).
• Ensure appropriate testing with quality control and support methods validation with R&D department is completed.
• Review and analyze moderately complex analytical and physical data generated from validation activities.
• Write validation final reports that present, summarize conclusions on the validity of the process based on the results of the analysis.
• Coordinate the facility qualification program by preparing the protocols, monitoring the execution, auditing the results and assisting production in resolving any identified problems
• Ensure accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities,
• Ensure critical deadlines are met for complex projects with quality assurance manager supervision.