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

Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)


In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Biopharma Report

biopharma industry report biopharmaceuticals
Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More