Experienced Manufacturing Executive

2 weeks ago

Dublin, Dublin City, Ireland beBeeManufacturing Full time €90,000 - €115,000
Manufacturing Excellence Manager

We are seeking an accomplished Manufacturing Manager to lead our team at a renowned Pharmaceutical organization based in Dublin.

  • Oversee nonconformance, CAPA, SICAR, Change Control and metrics oversight responsibilities.
  • Act as the category owner for all quality records and procedures.
  • Process, investigate and act as first responders to deviations.
  • Address and expedite product deviation under the company's quality management system procedures, ensuring compliance with regulatory agencies.
  • Monitor, investigate deviations and determine corrective and preventive actions to modify existing manufacturing or packaging process based upon trend, deviation, and related analyses.
  • Maintain unified product defect investigation operating procedures.
  • Provide technical expertise to optimize deviations management, corrective and preventive actions effectiveness, and prevent reoccurring events.
  • Maintain and monitor systems to ensure that all deviations received are appropriately investigated and concluded per the company's quality standards and procedures.
  • Communicate effectively with all levels of the organization, facilitating development of solutions to critical business issues, and defining objectives to enable effective metric generation and reporting.
  • 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.
Key Requirements:
  • 6+ years related work experience (manufacturing, process development, or quality assurance) 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.
  • Ability to defend processes, procedures, and decisions during regulatory inspections.

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