Collins McNicholas

Role Responsibilities:

  • Release of Finished and Semi-Finished Products
  • To meet Internal & External cGMP Requirements
  • By assisting in the completion of Annual Product Review (data collection, graphic analysis…)
  • By participating to the review and updating of the regulatory filing, with the collaboration of the regulatory department.
  • By completing quality assurance review of batch documentation as required:                                                                                                                                

– By making sure that critical deviations are investigated and resolved
– Set up a performance indicator
– Decide efficiently what is to be done with products

  • By ensuring the follow-up of the necessary corrective actions implemented in consequence of a quality failure
  • By reviewing and assessment of GMP critical systems
  • Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients, propose corrective actions and check that they are applied.
  • Participate in technical and scientific meetings, in training days, trade fairs, conferences… (technological intelligence…).  Provide to operations all guidelines and documents.
  • Keep up-to-date with the Regulation Evolution
  • Contribute to the Quality Assurance Plan Realisation

 

Role Requirements:

  • Education to meet the requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16.
  • Experience to requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16
  • Relevant 3rd honours degree with 3 yrs practising QP experience preferred
  • 2 yrs QA industrial experience in pharma

 

For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email eloisa.ruiz@collinsmcnicholas.ie

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