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 

Support the GxP and Regulatory compliance of Dechra Products by developing audit systems which will ensure process and product compliance with applicable GMPs/GDPs throughout the product lifecycle.

Develop, approve and monitor the risk-based GxP audit programme and budget for Dechra DPMS.

Develop and support inspection readiness at Dechra Internal Manufacturing sites, sustaining their ability to successfully conclude regulatory inspections for Dechra's products.

Provide US and European regulatory intelligence, train Subject Matter Experts and provide internal consultancy for quality compliance implementation and FDA/EU GMP/GDP remediation projects in the Dechra Internal Manufacturing network.

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:

• Support all regulatory authority inspections at Dechra Internal Manufacturing Sites and at key Identified External Network Manufacturing Sites by providing expertise (e.g. stress tests, mock inspections, inspection preparations, backroom support and review or preparation of responses to deficiencies) and on-site presence as required.
• Develop audit systems to ensure key elements of the Dechra GxP Quality Management System and the requirements of the product licences / marketing authorisations are effectively implemented throughout the internal and external manufacturing network (as required) across the product's registered lifecycle in compliance with all applicable ISO, ICH, FDA, EU and national regulatory requirements for GMP/GDP.
• Lead GMP/GDP audits for Dechra DPMS based on specific expertise, criticality and complexity.
• Periodically assess the liability, regulatory and/or quality risk to Dechra's products, reputation and operating licenses through the programme of audits and risk assessments, escalating and reporting the results accordingly.
• Maintain oversight of the Dechra DPMS audit master schedule and coordinate the audit planning with the wider audit team and Group Risk Management to ensure that products currently marketed, supply chain optimisation exercises, service providers as well as transportation and distribution networks are all being adequately monitored.
• Recruit, lead, train and develop, as required, the team of quality and compliance experts (specialised in auditing different GMP/GDP areas) across the business, in order to keep the business abreast of ongoing developments through benchmarking activities, whilst proactively identifying and addressing any gaps relating to product quality and GxP compliance.
• Support the Dechra DPMS Quality groups as well as the Dechra functional specialties (Product Development, Regulatory Affairs, Business Development, Procurement and Commercial Operations) by providing subject matter expertise, review(s) and in-house consultancy on request.
• Provide Group Quality Director with a fully independent and autonomous investigative and report that provides a clear liability and risk assessment related to quality and GMP/GDP regulatory compliance.
• Disseminate regulatory intelligence related to industry best practice, upcoming regulations, audit/inspection trends as well as general QMS training and product quality knowledge.
• Support the QMS Manager in the configuration of the eQMS supplier qualification, audit and inspection processes within the eQMS system.

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 have/are:

• Educated to Degree level (or equivalent qualification) in Chemistry, Biology, Pharmacy, Pharmaceutical Science, Life Science or comparable discipline.
• Extensive experience in Pharmaceutical industry with hands on experience in or supporting operations
• Line management experience is desired
• Experience of auditing quality systems / manufacturing / releasing for a variety of pharmaceutical dosage forms (including aseptic parenteral products) is essential.
• Hosted or supported multiple regulatory inspections by FDA, MHRA, EMA and other regulatory agencies.
• Excellent working knowledge of FDA and EU GMPs/GDPs, especially in the interpretation of requirements and guidance for the development, manufacture, control, and distribution of commercial product
• Proven ability of accurate and timely completion of tasks

About the Company

About Your Application

All applications received are reviewed by our internal talent acquisition team and we will get in touch if your skills and experience match what we’re looking for. Should you not hear back from us within 28 days please don’t be too disappointed – we may keep your CV on our database for any future vacancies which may be suitable and we encourage you to keep an eye on our careers site. For any questions or queries, please contact us at recruituk@dechra.com

Dechra Pharmaceuticals PLC