Our client, a leading life sciences manufacturer based in Dublin, is seeking an experienced
Authorised Person (AP)
to join their team on a contract basis.
This role will play a key part in supporting the extension of their state-of-the-art manufacturing facility, ensuring all products released during this period continue to meet the highest standards of quality, compliance, and regulatory oversight.
Key Responsibilities
* Act as an
Authorised Person
for batch disposition, ensuring all products meet GMP, regulatory, and internal quality requirements.
* Review and approve batch documentation, investigation reports, change controls, deviations, CAPAs, and validation protocols associated with the plant extension project.
* Provide quality oversight to manufacturing, engineering, and project teams involved in the facility expansion.
* Support tech transfer, scale-up, and commissioning activities by ensuring compliance with relevant guidelines.
* Collaborate with cross-functional teams to resolve quality issues and maintain uninterrupted product release timelines during project activities.
* Ensure all processes, equipment, and documentation introduced as part of the plant extension meet regulatory expectations.
* Participate in internal and external audits, contributing to continuous improvement initiatives.
* Maintain up-to-date knowledge of EU GMP, Annex 16, and relevant regulatory expectations.
Requirements
* Eligible to act as an
Authorised Person
within Ireland/EU (meeting the educational and experience requirements outlined in Directive 2001/83/EC).
* Minimum 3–5 years' experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
* Strong understanding of batch release processes, quality systems, and regulatory frameworks.
* Experience supporting site expansions, capital projects, tech transfers, or large-scale manufacturing changes is a significant advantage.
* Excellent communication, documentation, and decision-making skills.
* Ability to work effectively within cross-functional project teams.
If you are looking for a new and refreshing role or have any questions about the position, then give me a call, drop me a message, or apply directly below and get ahead of the crowd I look forward to hearing from you.
For a confidential discussion about this role, or to apply, send your CV to or call me, Corey Buckley, Recruitment Consultant – Head of Life Sciences – US/Europe, at Please feel free to visit my LinkedIn profile to see my references/recommendations