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:

 

Responsibilities:

 

  • 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

 

Requirements:

  • 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

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