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QC Control Analyst III

Job description

Responsibilities

  • You will conduct routine chromatographic and wet chemistry testing of raw materials, in process and finished products and stability samples to make sure they are in strict compliance with GLP & cGMP procedures.
  • Assist in the transfer (and troubleshooting, where required) of analytical methods to the QC laboratory as and when required.
  • Co-ordinate investigations and ensure OOS results are escalated and initialising relevant FARs and further studies if required.
  • Be a SME for third party inspection and review and approve non-chromatographic and chromatographic data.
  • Support continuous improvement projects such as 6S and lean processes for the laboratory
  • Management of QC SOPs, change controls, deviations and IRFs.

 

Requirements

  • Must have a bachelor in science or related field with experience in chemistry / biochemistry (chromatographic, wet chemistry and peptide analysis) techniques.
  • Requires 5 to 7 years in a regulated pharmaceutical or QC environment with a good working understanding of cGMP

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

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