Qualified Person

3 weeks ago

Cork, Cork, Ireland ACCPRO Full time

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Qualified Person (QP) – Pharmaceutical Industry

Location: Kerry

Employment Type: Full-time (On-site only)

My client, an Irish-owned manufacturer operating for over 35 years, produces a wide range of veterinary pharmaceutical and nutritional products. Their facility features modern cleanrooms that meet pharmaceutical production standards. Licensed to handle and process veterinary medicines, the company is committed to quality, compliance, and innovation in animal health.

The Qualified Person (QP) will be responsible for the certification and release of veterinary medicinal products, ensuring full compliance with GMP regulations and quality standards. The successful candidate will work closely with the QA Manager and cross-functional teams to maintain product integrity and regulatory compliance throughout the manufacturing process.

Key Responsibilities

  • Certify batches of veterinary medicinal products in accordance with EU Directives 2001/82/EC and 2001/83/EC.
  • Ensure full compliance with GMP, GDP, and relevant regulatory requirements (including HPRA).
  • Review and approve manufacturing and testing documentation, including batch records, deviations, and investigations.
  • Lead and support internal audits and inspections, including preparation and follow-up activities.
  • Oversee the implementation of CAPAs and change controls related to product quality.
  • Provide QP oversight for third-party manufacturing and testing partners.
  • Collaborate closely with the QA Manager to ensure continuous improvement of the quality system.
  • Support regulatory submissions and product lifecycle activities from a quality perspective.
  • Maintain up-to-date knowledge of veterinary pharmaceutical regulations and industry best practices.

Requirements

  • Hold a relevant scientific degree.
  • Possess a recognised Qualified Person status under EU legislation.
  • Demonstrate strong knowledge of GMP regulations and pharmaceutical quality systems.
  • Have prior experience working as a QP in a GMP-regulated pharmaceutical environment.
  • Must be currently based in Ireland and willing to work full-time on-site in County Kerry.
  • Strong communication, leadership, and decision-making skills.

For further information contact Alan on alan@accpro.ie

Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionQuality Assurance and Manufacturing
  • IndustriesPharmaceutical Manufacturing, Veterinary Services, and Biotechnology Research

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