Quality Associate - External Network - Canada

Job Introduction

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

Dechra is 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

Reporting to the Quality Manager External Network (CA), responsible for ensuring that documents make up the Quality Management System (QMS) related to finished products imported on the Canadian market are reviewed and approved by External Network (CA) Quality team, including (non-exhaustive list) :

• Changes Control
• Complaints
• Deviations
• Corrective and preventive action plan (CAPAs)
• Annual product quality reviews (APQRs)
• Finished products ongoing stability program documentation
• Records supporting batch release to the Canadian market

This is a hybrid role which will require 2-3 days per week on-site in Pointe-Claire,Quebec

Role Responsibility

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

Key Responsibilities and core tasks :

Support the Quality Manager External Network (CA) in the development and management of the Dechra Canada Pharmaceutical Quality System (PQS).

Support the Quality Manager External Network (CA) :

• Maintenance of the quality management system associated with the supply of products to the CA market
• Management of authorised activities ensuring the accuracy and quality of records
• Ensure initial and continuous training programmes are implemented and maintained
• Coordination of recall activities
• Provide CA review and work with cross functional teams involved in the management of relevant customer complaints to ensure they are handled effectively
• Ensure suppliers are approved
• Support the approval of any subcontracted activities which may impact on GDP
• Support the self-inspections programme ensuring they are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
• Keep appropriate records of any delegated duties
• Collation and review of documentation required to enable the disposition of returned, rejected, recalled or falsified products
• Collation and review of documentation required to enable the approval of any returned product to facilitate a decision as to its suitability for disposition to saleable stock
• Ensuring any additional requirements imposed on certain products by national legislation are adhered to
• Compile and review appropriate Key Performance Indicators (KPI’s) that facilitate ongoing assessment of the effectiveness of the site QMS
• Review the QMS currently in operation at site and work with the wider global External Network Quality team and other functions to proactively ensure the QMS meets current and emerging Canadian GDP requirements and where necessary to support the development and maintenance of Quality Plans to meet and maintain compliance
• Work with key stakeholders such as the Dechra Canada General Manager, Dechra Canada Functional Leads, External Network Technical Management, Product Development and / or Regulatory Affairs on CA specific Product Quality Reviews, Quality Technical Agreements, Audit coordination, Recalls, Complaints, Deviations and Change Controls
• Ensure GDP requirements are embedded in the Dechra Canada logistics and supply chain activities
• Ensure effective cross functional communication ensuring timely identification and resolution of issues
• Support Contract Manufacturer, Supplier, Regulatory and Customer audits
• Ensure situations with the potential to compromise quality are highlighted, risk assessed and addressed in order to assure measures for improvement and issue prevention are undertaken

As a member of the External Network Quality Team :

• Confirm Dechra quality expectations from the CMO network demonstrating maturity, integrity experience and knowledge of subject
• Ensure Quality requirements from CMOs, customers and suppliers are met in relation to existing business and from new product introductions.
• Support the Quality Manager External Network (CA) in the creation / review of Technical / Quality Agreements with suppliers and contract manufacturing organisations;
• Support the Quality Manager External Network (CA) on the review and approval of Contract Manufacturer documentation

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 excited to hear from those who have / are :

Must hold a university degree; in Canada this must be a Canadian 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.

Minimum 2 years of relevant practical experience in a quality role.

Fully bilingual French-English is required

Demonstrated pharmaceutical quality experience, including audit, batch record review, change control, complaint handling and Investigations experience.

Knowledge of pharmaceutical manufacturing, packaging, testing, distribution processes and associated regulatory GMP / GDP requirements eg working knowledge of Health Canada GMPs.

Knowledge of US FDA applicable CFR’s and Eudralex volume 4 is considered as an asset.

Experience supporting regulatory inspections, supplier audits and self-inspections.

Proficient with Veeva Software is an asset.