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 colleague 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 

Development and realisation of an integrated Quality Management System (QMS) and Quality Policy for Dechra (Bladel) in order to assure processes and production are compliant with current GMP regulations (as applicable).

Role Responsibility

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

Manage and lead the Quality Unit consisting of QA department and QC laboratory to assure the quality departments operate effective and efficient to achieve Quality oversight and an appropriate QMS.

Main expectations and responsibilities:

• Inform staff about the quality policy, how to implement the policy requirements, how to cooperate with other departments in order to achieve an acceptable quality level, how to execute their tasks and responsibilities.
• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
• Monitoring of compliance with the requirements of Good Manufacturing Practice
• Maintain oversight on status of the Quality system and the progress of implementation of improvement activities.
• Management reviews of process performance, product quality and of the quality management system and advocating continual improvement
• Intervene in case of organizational, technological or other imperfections and assure measures for improvement and prevention are undertaken.
• To ensure that the required initial and continuing training of the quality personnel is carried out and adapted according to need
• Planning of Quality related activities and indicate the priorities.
• Manage the review, improve and approval of change requests, corrective & preventative actions and investigations.          
• Assure adequate staffing of the Quality Unit.
• Assure Quality oversight in order to realize a quality level in compliant with relevant GMP regulations for the production, distribution and quality control of pharmaceutical products.
• Manage the testing and release of raw materials, primary packaging materials, intermediate products, finished products (insourced and outsourced) by the appropriate staff within the Quality Unit.
• Manage the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality

• Assure the execution of investigations necessary to maintain the acceptable Quality level is performed within the Dechra Bladel site.
• Manage the review and approval of master manufacturing protocols, batch manufacturing records, specifications, QC batch test records, validation protocols and records
• Assure implementation and maintenance of regulatory requirements and changes in existing regulatory requirements for the Bladel site.
• Assure a GMP compliant Quality Management System is in place and maintained for the site
• Manage/write/authorise technical Quality Agreement for suppliers and contract manufacturing organisations
• Responsible for the approval and monitoring of suppliers, contract manufacturing organisations, GMP service providers and other GMP related outsourced activities;
• Assure the appropriate handling of deviations, complaints, CAPAs and change control requests.
• Responsible for the site training program to assure staff is properly trained for their tasks.
• Assure oversight of hygiene, validation and training.
• Responsible for QA review for production and validation documents, protocols to assure compliance with relevant GMP regulations.
• Responsible for archiving of GMP documents and retain samples.
• Initiate and coordinate recalls as per applicable procedures.

• Responsible for the execution of internal and external audits.
• Lead audits conducted by regulatory authorities and customers and assure appropriate response to observations made during audits.
• Maintain the site accreditations (GMP, Opiates, Veterinary)
• Report Quality related progress to the group quality director
• Report operational related progress to the site director
• Responsible for the department budget
• Remain compliant with Site regulations (environmental and company regulations)
• Responsible cooperation with Operations responsible for the monitoring and control of the manufacturing environment.

The Ideal Candidate

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:

• Excellent people manager with organizational skills
• Strong communicator with social skills
• Pragmatic
• Relevant Bachelor degree (Pharmacy, Chemistry, Biochemistry or equivalent)
• Preferably: WO, Pharmacy (industrial pharmacist) and/or Qualified person conform article 29 directory 81/851/EEG
• Relevant QA Manager experience (>5 years)
• GMP/GLP
• Quality Management Systems in compliance with GMP/GLP and/or FDA and/or ISO
• Automated data processing
• Verbal and written knowledge of both the Dutch and English language

About the Company

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