Quality Control Specialist
il y a 4 semaines
Job Overview
Thank you for your interest in exploring a career with Dechra.
Dechra is a dynamic, global leader in the veterinary pharmaceutical industry, specializing in the development, production, marketing, and distribution of premium products exclusively for veterinary professionals worldwide.
Our core values are deeply ingrained in our culture and resonate throughout our family of nearly 2000 employees globally. From production to promotion, our principles of ( D )edication, ( E )njoyment, ( C )ourage, ( H )onesty, ( R )elationships, and ( A )mbition guide our daily operations and business practices.
Position Summary
Reporting to the Quality Manager for the External Network, this role is essential in ensuring that the documentation forming the Quality Management System (QMS) related to finished products in the Canadian market is meticulously reviewed and approved by the External Network Quality team. Key responsibilities include:
- Change Control Management
- Handling of Customer Complaints
- Management of Deviations
- Implementation of Corrective and Preventive Action Plans (CAPAs)
- Conducting Annual Product Quality Reviews (APQRs)
- Overseeing Finished Products Stability Program Documentation
- Maintaining Records for Batch Release to the Canadian Market
***This role operates in a hybrid model requiring on-site presence several days a week.***
Key Responsibilities
The successful candidate will undertake a diverse range of responsibilities, including:
- Assisting the Quality Manager in the development and oversight of the Dechra Canada Pharmaceutical Quality System (PQS).
- Maintaining the quality management system associated with product supply to the Canadian market.
- Ensuring the accuracy and quality of records related to authorized activities.
- Implementing and maintaining training programs for initial and ongoing education.
- Coordinating recall activities as necessary.
- Collaborating with cross-functional teams to manage customer complaints effectively.
- Ensuring supplier approvals are in place.
- Supporting the approval of subcontracted activities impacting Good Distribution Practices (GDP).
- Facilitating self-inspections to ensure compliance and corrective measures are executed.
- Maintaining records of delegated responsibilities.
- Reviewing documentation for the disposition of returned or rejected products.
- Ensuring compliance with national legislation for specific products.
- Compiling and assessing Key Performance Indicators (KPIs) for ongoing QMS effectiveness.
- Collaborating with the global External Network Quality team to ensure QMS compliance with Canadian GDP requirements.
- Engaging with key stakeholders on Product Quality Reviews and related activities.
- Ensuring GDP requirements are integrated into logistics and supply chain processes.
- Promoting effective communication across functions to identify and resolve issues promptly.
- Supporting audits of Contract Manufacturers, Suppliers, and Regulatory bodies.
- Identifying and addressing potential quality risks to implement improvements.
As a member of the External Network Quality Team, responsibilities include:
- Confirming Dechra's quality expectations from the Contract Manufacturing Organization (CMO) network.
- Ensuring compliance with quality requirements from CMOs, customers, and suppliers.
- Assisting in the creation and review of Technical/Quality Agreements with suppliers.
- Supporting the Quality Manager in reviewing and approving Contract Manufacturer documentation.
Ideal Candidate Profile
At Dechra, we value diversity and encourage applications from individuals with varied backgrounds. The ideal candidate will possess:
- A university degree in a relevant scientific field recognized by Canadian accreditation.
- A minimum of 2 years of practical experience in a quality role.
- Bilingual proficiency in French and English.
- Demonstrated experience in pharmaceutical quality, including audits and investigations.
- Knowledge of pharmaceutical manufacturing and regulatory requirements.
- Experience with regulatory inspections and supplier audits.
- Familiarity with Veeva Software is advantageous.
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