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Microbiologist

Job description

YOU will be responsible for supporting the establishment, validation, qualification & ongoing support of pharmaceutical cleanroom and all associates test programs.

YOU will provide microbiological support in the establishment of the Contamination Control Strategy & ongoing support to Operations, in ensuring operational goals & objectives are achieved for the plant.

This role plays a key part in establishing, maintaining & enhancing the Microbiological monitoring programs developed to ensure the sterility assurance of the product.

Job Responsibilities

  • Review and approve microbiological procedures, protocols, and reports. Support validation & engineering qualification activities.
  • Provide support & technical expertise to ensure best practices.
  • Support the development of the site strategy for cleanroom behaviors, aseptic practices & training of personnel.
  • Lead and provide direction in all areas relating to the sterility assurance of the product.
  • Microbiological systems & associated documents management.
  • Provide expertise to other functions on quality-related issues e.g regulatory requirements, sampling principles etc.
  • Evaluate quality events ensuring compliance with cGMP & quality standard requirements. Ensure timely & effective actions are implemented & CAPA effectiveness checks are conducted.

Job Requirements

  • Level 8 in Microbiology or a related discipline
  • 3+ years’ experience within a pharmaceutical GMP environment, ideally within a Microbiological function.
  • Working knowledge of FDA, HPRA & pharmaceutical industry microbiological requirements & associated manufacturing controls is desirable.
  • Experience in problem-solving & process improvements is desirable.
  • CAPA experience, Risk Management & Process Validation is also desirable.

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

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