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Avishek Singh
Life Science

00353872827991
[email protected]
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Details

Senior Manufacturing Manager


Reference:AS34393 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: BD Manager, Manufacturing and Technology Manager

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.

Ideally the person will have experience in managing and executing total quality management systems for the External Supply organization (Raw Materials Categories, Devices, and Contract Manufacturing).

Responsible for:

  • Position is expected to 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 Skills:
  • 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
  • Able to defend processes, procedures, and decisions during regulatory inspections.
If interested in this posting please feel free to contact Avishek Singh at [email protected] or 0872827991 for further information.