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Veterinary Pharmaceutical Quality Specialist
2 weeks ago
We are seeking a highly qualified and experienced Qualified Person to join our team. As a Qualified Person, you will be responsible for the certification and release of veterinary medicinal products, ensuring full compliance with GMP regulations and quality standards.
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.
- Strong communication, leadership, and decision-making skills.
About the Role:
This is an exciting opportunity to work in a dynamic and innovative company that produces a wide range of veterinary pharmaceutical and nutritional products. Our facility features modern cleanrooms that meet pharmaceutical production standards, and we are committed to quality, compliance, and innovation in animal health.
Benefits:
This role offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a positive and inclusive work environment, and we welcome applications from candidates who share our values.
