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QC Specialist (12 month fixed term contract)

Location: Dublin, Ireland Job reference: R-180014 Date posted: 09/18/2023

You will be responsible for:

  • Provide QC SME support to the QC department providing day to day technical guidance to QC personnel
  • Support the QC management team as required
  • Lead and drive execution of method development and transfer, participating in training and execution as both the receiving and transfer laboratory.
  • Lead and complete execution of timely deviations, events and change controls.
  • Training leads in specific assays overseeing the execution of all training activities for all new personnel.
  • Leading the method validation / transfer activities with the generation of protocols and reports and support for ad hoc regulatory supporting studies.
  • Drive continuous improvement initiatives thus increasing efficiency as per the QC departments OE program
  • Quality control leads on the analytical lifecycle governance program, driving implementation in Alexion Dublin.
  • Provide SME trouble shooting support and coaching to testing analysts as required.

You will need to have:

  • Bachelor’s degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science with a minimum of 7-10 years of laboratory experience in a cGMP laboratory.
  • Good technical knowledge in the area of Chemistry and Biochemistry.
  • In depth knowledge of current regulatory requirements for Chemistry, Biochemistry and Microbiology methods in support of cGMP operations supporting clinical and commercial manufacturing
  • Good experience in deviation methodology and method trouble-shooting
  • Excellent report writing and technical writing skills.

We would prefer for you to have:

Experience in Method Transfer and Validation Activities


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