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QA Specialist

  • Sector: Science & Pharma
  • Contact: Davin Ferguson
  • Contact Email: davin.ferguson@collinsmcnicholas.ie
  • Job Ref: 17840

QA Specialist – Sligo

 

QA Specialist required in an expanding pharmaceutical company in Sligo. Your role as QA Specialist is to ensure that products manufactured meet requirements of end users, Regulatory Authorities and the company and to ensure they are manufactured in accordance with the relevant GMPs.

 

This role is offered out on a contract basis initially with a view to a more long-term permanent role in time. The salary will be competitive and it offers an excellent opportunity to join a company who are at the cutting edge of technology within the sector and who are renowned for their positive workplace culture.

 

Key Responsibilities:

  • Ensure the batch and its manufacture comply with the provisions of the marketing authorisation.
  • Ensure manufacture has been carried out in accordance with Good Manufacturing Practice.
  • Ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records.
  • 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 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 all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so.
  • Ensure all audits have been carried out as required by the quality assurance system.
  • 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.
  • Other duties as assigned.


A Quality, Science or Engineering Degree is desired. A minimum of 3 years industry experience is required. Ideally pharma but medical devices will be considered also. Previous Biologics sector experience would be a huge advantage.


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For a confidential discussion and more information on the role, please contact Davin Ferguson.

davin.ferguson@collinsmcnicholas.ie

071 9140251