AddressResponsible for the supporting the Quality Manager – External Networks (UK/EU) by providing Quality oversight of Dechra Contract Manufacturing Organisation (CMO) network.
You will also assist with the development of systems and processes that ensure that Dechra fulfils its obligations as a Marketing Authorisation Holder in the management of CMO organisations through a partnership approach.
Your tasks will also include establishing and maintaining processes that enable the impact of quality within the CMO network to be tracked, managed and visible enabling effective communication to key stakeholders within DPM&S and the wider Dechra business.
Main Responsibilities- To confirm the Dechra quality expectations from the CMO network demonstrating maturity, integrity experience and knowledge of subject.
- To support the Quality Director – External Network in the definition, development, implementation and refinement of appropriate Key Performance Indicators (KPI’s) for senior management in order to monitor the effectiveness of the external CMO network.
- To ensure effective implementation and management of Product Quality Reviews (PQR’s) and Quality Technical Agreements (QTA’s).
- To support CMO network management in recalls, complaints, change controls, deviations, sanctions as per the contractual and service level agreements.
- Support the development and maintenance of risk assessment process (in line with ICH Q9 or equivalent Regulatory Guidance) and to monitor KPI’s across the CMO network to drive improvements in performance of the CMO network.
- Perform batch disposition where required based on geographic requirements / agreed responsibilities.
- Conduct API and Finished Product disposition processes (where required by geography and regulation) to support Dechra supply chain.
- Lead and / or participate on CMO projects, new technology and technical transfer within CMO network and associated validation, problem shooting including liaising with technical, commercial and supply chain stakeholders.
- To ensure logistics and supply chain is quality compliant and supports Dechra’s strategic aims. To provide quality guidance in order to ensure Good Distribution Practice (GDP) across the supply chain and to ensure quality adherence across the supply chain in its entirety.
- Contribute to manufacturing, supply chain and technical services in daily work, projects and programmes, with the focus being to ensure quality is embedded at all stages of products from New Product Introduction (NPI), transfer, manufacture and distribution.
- Ensure effective communication with to drive the quality agenda, to liaise and co-operate with all other Departments to ensure good communication and timely identification and resolution of issues.
- Report and create action plans, as necessary on changes in standards (internally and externally initiated) and on performance against standards.
- Liaise with suppliers with respect to quality incidents in supporting existing business and to provide quality oversight of new product introductions and technical transfers within the CMO network.
- Support and plan CMO, Supplier, Regulator and Customer audits.
- Demonstrated pharmaceutical quality experience, including working within quality systems such as audit programmes, change control, complaint handling and investigations.
- A thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements.
- Experience of supporting regulatory inspections, client audits and self-inspections.
- Technical knowledge to support quality and validation decision making.
- 5 plus years of relevant Quality Assurance experience.
- Proven Quality Specialist capabilities in a quality role associated with CMO management.
- Bachelor degree (Pharmacy, Chemistry, Biochemistry or equivalent).
Dechra is a global specialist in veterinary pharmaceuticals and related products business. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
We are a global leader in veterinary endocrinology and topical dermatology, have a broad portfolio of analgesia, anaesthetics and products for the treatment of pain, and are also recognised as innovators in other specialisations such as the treatment of equine lameness, nutrition and differentiated generics.
We deliver high quality products and services to veterinarians worldwide through our employees and a network of third parties to sustainably improve global animal health and welfare.
Everything we do is underpinned by our Culture and Values. They are important to us and have helped drive the Group’s success.
