JOB OFFER

JOB DETAILS

Title:
Quality Engineer
Location:
Mayo, Sligo
Job Type:
Mayo, Sligo

Quality Engineer

GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs.

We are hiring for a Quality Engineer for the Sligo region.

Job Requirements

  • Ensure manufacture has been carried out in accordance with Good Manufacturing Practice.
  • Ensure the batch and its manufacture comply with the provisions of the marketing authorisation.
  • Ensure all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes.
  • Ensure any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
  • Ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records.
  • Ensure all audits have been carried out as required by the quality assurance system.
  • Ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so.
  • Should in addition take into account any other factors of which they are aware which are relevant to the quality of the batch.
  • Should maintain their knowledge and experience up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
  • Ensure that they have gained the relevant knowledge and experience to certify a batch of a product type with which they are unfamiliar, for example because a new product range has been introduced, prior to certification.

Candidate Requirements

  • Third level qualification in a science discipline. Masters preferred.
  • 4 year’s plus experience within the pharmaceutical sector.
  • Excellent knowledge of relevant GMPs, regulations and current industry trends.
  • Highly motivated, enthusiastic, energetic individual with a goal focused attitude

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