Senior Manufacturing Manager (hybrid)
RK3737
12 Months
Dublin


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


The successful candidate will be responsible for managing and executing total quality management systems for the External Supply organization (Raw Materials Categories, Devices, and Contract Manufacturing)


Duties:

• Execute nonconformance, CAPA, SICAR, Change Control and metrics oversight responsibilities
• Act as the category owner for all quality records and procedures.
• The Specialist processes, investigates and acts as first responders to deviations.
• Addresses and expedites product deviation under the company's quality management system procedures, and ensures compliance with regulatory agencies.
• Monitors, investigates deviations and determines corrective and preventive actions to appropriate company authorities to modify existing manufacturing or packaging process based upon trend, deviation, and related analyses.
• Maintains unified product defect investigation operating procedures.
• Provides technical expertise to optimize deviations management, corrective and preventive actions effectiveness, and prevent reoccurring events.
• Maintains and monitors systems to ensure that all deviations received are appropriately investigated and concluded per the company's quality standards and procedures.
• Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting.
• May serve as the primary point of contact between Site Plant Quality and the corporate Supplier Quality Management team to ensure the quality of raw materials used at the sites.


Education and Experience :


• 6+ years related work experience (manufacturing, process development, or quality assurance) in in Biotech or pharmaceutical industry with demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems.
• Understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations.
• Thorough working knowledge of EU and US cGMPs regulations


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.