Qualified Person

Our Animal Health organisation are recruiting for a Qualified Person at our site in Milton Keynes.

Key Responsibilities:
Undertakes the duties of a Qualified Person as defined in Directives 2001/82/EC
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
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
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.
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
Engage in self inspection of the site QMS
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
Supporting senior QA leadership through QP decision making to drive continuous improvement and ‘fitness for purpose’
Partners with and supports other sites and functions as needed during the technical transfer of products into and out of the site
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
Acts as the point of focus for all compliance inspections of the sites e.g. internal and corporate audits as well as Regulatory Inspections
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:
Degree in Pharmacy, Chemistry, Biology or relevant biosciences discipline.
Eligible for nomination as a Qualified Person
Experience in performing EU Qualified Person batch certification
Experience of Sterile Product Pharmaceutical manufacturing QA is desirable but not essential
Post graduate experience in pharmaceutical manufacturing either in a QA or QC role
Supervisory or management experience desirable
Auditing experience desirable
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
Excellent interpersonal skills including good communication, conflict management and leadership
Excellent decision-making and problem solving skills
Excellent organisational & planning skills
Ability to work in team and solo capacity
Strategic and hands on approach to driving a Quality Culture and Improvements across site including mentoring individuals
Pragmatism and strong stakeholder management skills.