Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.

Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business

The Opportunity - Quality Associates (Oudewater)

The successful candidates will support the Quality Manager with:

• The development of the pharmaceutical quality systems (PQS) at the Oudewater site.
• The maintenance and management of the PQS.
• The management of processes that enable the assessment of quality within the Contract Manufacturing (CMO) network to be tracked, managed and trended enabling effective communication to key stakeholders within DPM&S and the wider Dechra business.
• Potential for future progression to RP role for the right candidate 

Role Responsibility

The Challenge

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

• Providing 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. 

• Updating  / reviewing existing procedures to ensure all processes required by article 99(6) of Regulation (EU) 2019/6 on veterinary medicinal products – Good distribution practices (GDP) for veterinary medicinal product are in place and are operating effectively at the Oudewater facility.

• Supporting the review of quality deliverables from External Network facilities confirming Dechra’s quality expectations while demonstrating maturity, integrity experience and knowledge of subject.

• Supporting the Quality Manager 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 Oudewater PQS.

• Supporting the Quality Manager where required with Product Quality Reviews (PQR’s) and Quality Technical Agreements (QTA’s).

• Supporting the Quality Manager in the management in recalls, complaints, change controls, deviations, CAPA activities as required.

• Reviewing External Network specifications, batch manufacturer, packaging, testing and validation activities for compliance against current GMP expectations and marketing authorisations.

• Supporting CMO projects, new technology and technical transfer within CMO network and associated validation, problem shooting including liaising with technical, commercial and supply chain stakeholders.

• Contributing to CMO manufacturing, supply chain and technical services in daily work, projects and programs, with the focus being to ensure quality is embedded at all stages of products from New Product Introduction (NPI), transfer, manufacture and distribution. 

• Ensuring effective communication to drive the quality agenda, to liaise and co-operate with all other departments to enable timely identification and resolution of issues

• Reporting and creating action plans as necessary on changes in standards (internally and externally initiated) and on performance against standards.

• Liaising 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

• Supporting and planning Supplier, Regulator and Customer audits

The Ideal Candidate

About You

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who are fluent in English and Dutch, educated to at least Bachelor Degree level (Pharmacy, Chemistry, Biochemistry or equivalent) , and have :

• Demonstrated pharmaceutical quality experience, including working within quality systems such as audit programs, change control, complaint handling and Investigations.

• A thorough knowledge of pharmaceutical distribution, manufacturing, packaging, testing, and associated global regulatory GDP/GMP requirements.

• Experience of supporting audits and self-inspections

• Appropriate, relevant Quality Assurance experience.

• Eligibilty to be considered for future RP role. 

Dechra Pharmaceuticals PLC