• 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 analyse 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.

Skills

• Bachelor of pharmacy or science
• (5-9) year of experience
• Computer knowledge of Microsoft excel, word as well as soft skills
• Good English language skills