Qualified Person (QP) – Onsite, Full‑Time, Permanent
Location:
Kerry
Job Type:
Full‑time, Permanent
My client, an established life sciences organisation working across human and
veterinary medicinal products
, is seeking an experienced
Qualified Person
to join their expanding Quality team. This is a fantastic opportunity to take on a key leadership position within a high‑compliance, GMP‑focused environment.
Key Responsibilities
* Perform QP certification and release of batches in line with EU GMP and Marketing Authorisations.
* Support the Quality Management System (QMS) including deviations, CAPA, change control, and investigations.
* Lead preparation for regulatory inspections and customer audits.
* Review and approve GMP documentation (SOPs, validation documents, manufacturing records).
* Provide QP oversight across validation, qualification, and tech transfer activities.
* Drive quality risk management, data integrity initiatives, and continuous improvement.
* Collaborate across Manufacturing, QA, QC, Regulatory, and Supply Chain teams.
* Support external manufacturing and supplier quality oversight as required.
Requirements
* Recognised Qualified Person (QP) status with prior QP experience of 2+ years
under EU GMP
* Ability to work
onsite
at the designated facility as required (this could be between 3-5 days onsite)
* Degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or equivalent (QP‑eligible discipline)
* Strong working knowledge of EU GMP, ICH guidelines, and QMS processes
* Experience with deviations, CAPA, change control, investigations, OOS/OOT, and complaints
* Excellent communication, decision‑making, and problem‑solving skills
Nice to Have:
Experience with sterile/aseptic operations, biologics, tech transfers, or electronic QMS/LIMS.
For further information, contact Alan on