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, dedicated to the research, production, marketing, and distribution of premium products tailored exclusively for veterinarians around the globe.
Our organizational values are deeply ingrained in our culture and resonate within our family of nearly 2000 employees worldwide. From production to promotion, our core principles of (Dedication, Enjoyment, Courage, Honesty, Relationships, and Ambition) guide our daily operations and business practices.
Position Summary
Reporting to the Quality Manager of the External Network, this role is pivotal in ensuring that the documentation forming the Quality Management System (QMS) for finished products imported into the Canadian market is thoroughly reviewed and sanctioned by the External Network Quality team. Key responsibilities include:
- Change Control
- Handling Complaints
- Managing Deviations
- Overseeing Corrective and Preventive Action Plans (CAPAs)
- Conducting Annual Product Quality Reviews (APQRs)
- Documenting ongoing stability programs for finished products
- Maintaining records that support batch release for the Canadian market
***This position is hybrid, requiring 2-3 days per week on-site.***
Key Responsibilities
The successful candidate will undertake a diverse range of responsibilities, including:
- Assisting the Quality Manager in the establishment and oversight of the Dechra Canada Pharmaceutical Quality System (PQS).
- Maintaining the quality management system related to product supply for the Canadian market.
- Ensuring the accuracy and quality of records associated with authorized activities.
- Implementing and maintaining initial and ongoing training programs.
- Coordinating recall activities as necessary.
- Collaborating with cross-functional teams to effectively manage customer complaints.
- Ensuring supplier approvals are in place.
- Supporting the approval of subcontracted activities impacting Good Distribution Practices (GDP).
- Facilitating self-inspections and ensuring corrective measures are enacted.
- Documenting and reviewing necessary records for product disposition.
- Ensuring compliance with national legislation for specific products.
- Compiling and analyzing Key Performance Indicators (KPIs) to assess the effectiveness of the site QMS.
- Reviewing the current QMS and collaborating with the global External Network Quality team to meet Canadian GDP requirements.
- Engaging with key stakeholders on various quality-related matters.
- Ensuring GDP requirements are integrated into logistics and supply chain operations.
- Facilitating effective communication across functions to identify and resolve issues promptly.
- Supporting audits of Contract Manufacturers, Suppliers, and Regulatory bodies.
- Addressing potential quality-compromising situations through risk assessment and improvement measures.
Team Contribution
- 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.
- Supporting the Quality Manager in reviewing and approving CMO documentation.
Candidate Profile
At Dechra, we value diversity and encourage candidates from all backgrounds to apply. The ideal candidate will possess:
- A university degree recognized by a Canadian institution in a relevant scientific field.
- A minimum of 2 years of practical experience in a quality role.
- Fluency in both French and English.
- Experience in pharmaceutical quality, including audits, batch record reviews, and complaint handling.
- Knowledge of pharmaceutical manufacturing and regulatory requirements.
- Experience with regulatory inspections and supplier audits.
- Familiarity with Veeva Software is advantageous.
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