Collins McNicholas

Collins McNicholas currently have an exciting opportunity for a Qualified Person with one of their clients in the Mid-West Region. This role is a permanent position.

The following are the key requirements for the role:




  • Manages the batch disposition process to ensure timely release of products
  • Ensures the batch disposition process maintains compliance with site practices & regulatory requirements
  • Disposition of products & materials in accordance with directive 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
  • Support major investigations, ensuring all product deviations are closed prior to batch release
  • Reviews and approves Product Quality Reviews 
  • Reviews and approves new and revised master manufacturing records.
  • Participates in cross functional teams as Quality/Qualified Person representative
  • Participate in third party/supplier audits, as required
  • Provide additional QP support to quality related issues, as required



  • Qualified Person status achieved with min 3 years of relevant work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA).
  • Biologics manufacturing experience desirable.
  • Aseptic / Sterile Drug Product manufacturing experience desirable.
  • Experience with IMP’s (Investigational Medicinal Products) desirable.

For a confidential discussion on the above role please contact Michael O’Leary on 061-512270

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 biopharmaceuticals industry report
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