Qualified Person

Job DescriptionOur 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/ECResponsible 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 releaseWorking 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 sitesWorking 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 policiesEngage in self inspection of the site QMSAct as a GMP Subject Matter Expert (SME) to facilitate site compliance with the companys Pharmaceutical Quality System. Mentor others to expand on-site compliance knowledgeSupporting senior QA leadership through QP decision making to drive continuous improvement and fitness for purposePartners with and supports other sites and functions as needed during the technical transfer of products into and out of the sitePartners 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 mannerActs as the point of focus for all compliance inspections of the sites e.g. internal and corporate audits as well as Regulatory InspectionsEither 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 companyQualifications, Skills & Experience Required:Degree in Pharmacy, Chemistry, Biology or relevant biosciences discipline.Eligible for nomination as a Qualified PersonExperience in performing EU Qualified Person batch certificationExperience of Sterile Product Pharmaceutical manufacturing QA is desirable but not essentialPost graduate experience in pharmaceutical manufacturing either in a QA or QC roleSupervisory or management experience desirableAuditing experience desirableProven technical ability including: knowledge of GMP/GCLPs, QMS, test method validation & equipment qualification, continuous improvement/business excellence and Lean and 6 Sigma is desirableExcellent interpersonal skills including good communication, conflict management and leadershipExcellent decision-making and problem solving skillsExcellent organisational & planning skillsAbility to work in team and solo capacityStrategic and hands on approach to driving a Quality Culture and Improvements across site including mentoring individualsPragmatism and strong stakeholder management skills.

Created: 2025-07-06