Qualified Person

MSD Animal Health Ireland; Milton Keynes; On-site; GBP 45,000 - 70,000; Full time

Job summary

A leading company in Animal Health is seeking a Qualified Person in Milton Keynes. This role involves ensuring compliance with GMP regulations, overseeing batch certifications, and collaborating with site management on quality assurance. Ideal candidates will have a relevant degree and experience in pharmaceutical QA, with strong leadership and problem-solving skills.

Qualifications

• Eligible for nomination as a Qualified Person.
• Experience in EU Qualified Person batch certification.
• Postgraduate experience in pharmaceutical manufacturing in QA or QC roles.

Responsibilities

• Undertake the duties of a Qualified Person as defined in Directives 2001/82/EC.
• Be responsible for the QP certification of Drug Products and Intermediates.
• Collaborate with site management to ensure UK site operations are fully GMP compliant.

Skills

GMP/GCLPs knowledge

Test method validation

Equipment qualification

Lean

Six Sigma

Interpersonal skills

Leadership skills

Problem-solving skills

Stakeholder management

Education

Degree in Pharmacy, Chemistry, Biology, or relevant biosciences discipline

Job description

Job Description

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

The Suitable Candidate Will Have Duties As Below

1. Undertake the duties of a Qualified Person as defined in Directives 2001/82/EC.
2. Be responsible for the QP certification of Drug Products and Intermediates in accordance with UK Code of Conduct for Qualified Persons, acting as a point of contact for queries related to QP certification and batch release.
3. Work with the Quality Compliance Manager to support the timely release of materials, components, and products, including UK Commercial and imported products controlled by the site.
4. Collaborate with site management to ensure UK site operations are fully GMP compliant, adhering to legislation, corporate governance, policies, procedures, and guidelines, and ensuring products and processes comply with regulatory dossiers.
5. Partner with the Quality Systems Manager to ensure the Quality Management System (QMS) is fit for purpose and harmonized across sites, in line with global policies.
6. Participate in self-inspections of the site QMS.
7. Act as a GMP Subject Matter Expert (SME) to facilitate compliance with the Pharmaceutical Quality System and mentor staff to expand on-site compliance knowledge.
8. Support senior QA leadership in QP decision-making to promote continuous improvement and 'fitness for purpose'.
9. Partner with and support other sites and functions during the technical transfer of products into and out of the site.
10. Proactively collaborate with other sites within the supply chain to ensure timely and GxP compliant receipt, release, and shipment of products and intermediates.
11. Serve as the point of contact for all compliance inspections, including internal, corporate audits, and regulatory inspections.
12. Coordinate with the Veterinary Medicines Directorate (VMD) regarding the routine release of biological products and resolve any issues impacting product quality and supply.

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 in sterile pharmaceutical manufacturing QA is desirable but not essential.
5. Postgraduate experience in pharmaceutical manufacturing in QA or QC roles.
6. Supervisory or management experience is desirable.
7. Auditing experience is desirable.
8. Proven technical ability, including knowledge of GMP/GCLPs, QMS, test method validation, equipment qualification, and familiarity with continuous improvement methods like Lean and Six Sigma.
9. Excellent interpersonal, communication, conflict management, and leadership skills.
10. Strong decision-making and problem-solving skills.
11. Excellent organizational and planning skills.
12. Ability to work independently and in teams.
13. Strategic and practical approach to fostering a Quality Culture and driving improvements, including mentoring.
14. Strong stakeholder management skills.