Qualified Person

Job Description

Our organization Animal Health is now recruiting a Qualified Person position at our site in Milton Keynes for our Animal Health division.

The suitable candidate will have duties as below:

1. Undertakes the duties of a Qualified Person as defined in Directives 2001/82/EC.
2. Responsible for the QP certification of Drug Product and Intermediates in accordance with UK Code of Conduct for Qualified Persons, acting as a point of contact for queries relating to QP certification and batch release.
3. Working with the Quality Compliance Manager to provide an efficient and effective service to support the timely release of materials, components and products including UK Commercial and imported products controlled by the sites.
4. Working with the site management, ensuring that the UK sites operate in a fully GMP compliant manner in accordance with all of the relevant legislation, corporate governance requirements (including reporting), policies, procedures and guidelines as well as ensuring that the products and processes are fully compliant with the filed regulatory dossiers for the products supported.
5. Working with the Quality Systems Manager ensuring that the Quality Management System (QMS) is fit for purpose, as far as practicable harmonized across the sites and in compliance with global policies.
6. Engage in self inspection of the site QMS.
7. Act as a GMP Subject Matter Expert (SME) to facilitate site compliance with the company’s Pharmaceutical Quality System. Mentor others to expand on-site compliance knowledge.
8. Supporting senior QA leadership through QP decision making to drive continuous improvement and ‘fitness for purpose’.
9. Partners with and supports other sites and functions as needed during the technical transfer of products into and out of the site.
10. Partners proactively with other sites within the supply chain to ensure that products and intermediates are received, released and shipped in a timely and fully GxP compliant manner.
11. Acts as the point of focus for all compliance inspections of the sites e.g. internal and corporate audits as well as Regulatory Inspections.
12. Either directly or through colleagues, liaises with the Veterinary Medicines Directorate (VMD) regarding the routine release of biological products and at other times to secure the resolution of complaints and other issues that might impact the quality and supply of the products supplied by or for the company.

Qualifications, Skills & Experience Required

1. Degree in Pharmacy, Chemistry, Biology or relevant biosciences discipline.
2. Eligible for nomination as a Qualified Person.
3. Experience in performing EU Qualified Person batch certification.
4. Experience of Sterile Product Pharmaceutical manufacturing QA is desirable but not essential.
5. Post graduate experience in pharmaceutical manufacturing either in a QA or QC role.
6. Supervisory or management experience desirable.
7. Auditing experience desirable.
8. Proven technical ability including: knowledge of GMP/GCLPs, QMS, test method validation & equipment qualification, continuous improvement/business excellence and Lean and 6 Sigma is desirable.
9. Excellent interpersonal skills including good communication, conflict management and leadership.
10. Excellent decision-making and problem solving skills.
11. Excellent organisational & planning skills.
12. Ability to work in team and solo capacity.
13. Strategic and hands on approach to driving a Quality Culture and Improvements across site including mentoring individuals.
14. Pragmatism and strong stakeholder management skills.

Closing date for applications: 28/03/2025