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Aseptic Operations Specialist

Aseptic Operations Specialist

Want to be recognised as the expert you are? Our client based in Sligo are now recruiting an Aseptic Operations Specialist to be part of their biologics operations team. Reporting directly to the Operations Manager, you will be the subject matter expert that supports the aspetic fill finish operations while providing technical and investigative support to the NPI and commerical production.  

Responsibilities:

  • Lead production aspect of product quality investigations in conjunction with Quality assurance including the assignment and management of corrective and preventative actions.
  • Review completed production documentation for quality, completeness, and cGMP (Good Manufacturing Practices) compliance.
  • Coordinate the execution of CAPA plan related to the sterility assurance of the department
  • Coordinate and review the execution of all the cleaning activities of the department
  • Perform daily GEMBA walks
  • Control and coordinate the supply and the release of cleaning agents and department gowning
  • Coordinate recovery clean after project works, shutdown or other unplanned activities.
  • Ensure continuous training and of operations people on all the quality aspect of the manufacturing operations
  • Guarantee the inspection readiness of the department and operators through a program of continuous improvement of aseptic behavior
  • Support internal and external audit inspection and collaborate to complete all the actions generated by them

Education and Experience:

  • You will have a 3rd level qualification to degree level in a relevant science/engineering with minimum 3 years’ experience in the pharmaceutical industry or biopharma industry in Quality/Operations role
  • From previous roles, you will have gained at least 1 years’ experience in an aseptic sterile fill finish manufacturing environment with 1+ years’ experience in a microbiological function in an aseptic sterile fill finish facility
  • As you will be working cross-functionally in this role, it is important that you have strong communication skills and ability to collaborate with others
  • Some experience that is desirable is knowledge of regulatory (FDA, HPRA) and technical requirements for biologics manufacture

For a confidential discussion and more information on the role, please contact Aideen Cummins.

aideen.cummins@collinsmcnicholas.ie

071-9140252