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Dechra Pharmaceuticals PLC: Quality Assurance Manager

Dechra Pharmaceuticals PLC

This is a Full-time position in Hampstead, QC posted February 18, 2021.

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 OpportunityDue to our continued international growth, we have an opportunity for an experienced Quality Manager to join our Manufacturing & Supply Division (DMP& S) based out of our Montreal Office.

The successful candidate will support in the development and management of the integrated Pharmaceutical Quality System (PQS) at Dechra (Canada) in order to ensure processes are compliant with current Canadian GMP/GDP regulations (as applicable), aligned and compliant with the wider Dechra systems and processes, as appropriate.

Reporting into the Quality Director, the Quality Manager will ensure the premises, systems and process at Dechra Canada meet the Canadian GMP requirements, that environmental controls for drugs during storage and transportation comply with GUI-0069, and to perform batch disposition of imported products.The successful candidate will work to ensure that the products, systems and processes at External Contract Manufacturer Organisations used to produce products meet the regulatory requirements of the market where the products are suppliedThe 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:Developing and managing the integrated Pharmaceutical Quality System (PQS) at Dechra (Canada) in order to ensure processes are compliant with current Canadian GMP/GDP regulations and aligned and compliant with the wider Dechra systems and processes.Ensuring that premises, systems and process at Dechra Canada meet the Canadian GMP requirements, that environmental controls for drugs during storage and transportation comply with GUI-0069,and performing batch disposition of imported products.Ensuring that all products released to the Canadian Market meet or exceed market requirements .Ensuring that the products, systems and processes at External Contract Manufacturer Organisations used to produce products meet the regulatory requirements of the market where the products are supplied (Canadaand US)About YouHere at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life.

You should note though that this is a regulated position and consequently applicants should have:ACanadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.2 years plus years of relevant practical experience in a role that will enable you to be identified as the person in charge of quality control as defined within Health Products and Food Branch Inspectorate Guidance Document Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines – Veterinary Drugs GUI-0012 section C.02.006 personnelA thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements eg working knowledge of Health Canada GMPs, US FDA applicable CFR’s and Eudralex volume 4Extensive demonstrated pharmaceutical quality experience, including audit, batch record review, change control, complaint handling and Investigations experience.Experience of hosting / supporting regulatory inspections, client audits and self-inspectionsSolid understanding of the requirements of an effective Pharmaceuticals Quality SystemTechnical knowledge to support quality and validation decision makingPlease note that there will be a degree of travel within US/Canada associated with this role.About Your ApplicationAll 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.