Specialist, Quality Assurance, Compliance and Documentation (m/f/d)
Qualifications:Education / Experience Required:
- Must hold a science degree B.Sc. (e.g., Biochemistry, Biology, Microbiology, Chemistry, etc.).
- 5 years of experience in Quality Assurance and/or Quality Control in the Pharmaceutical Industry.
- Experience in Pharmaceutical Manufacturing or Laboratory environments is preferred.
- Developed expertise of the Canadian Food and Drugs Act and Regulations, Policies and Guidelines, and solid understanding of the Business environment, culture, products, and service areas.
- Team Player
- Organizational and time management skills
- Communication Skills (Verbal and Written) with Internal and External Customers (e.g., Health Canada, AbbVie Global)
- Ability to work with minimum supervision
- Strong interpersonal skills
- Extensive working knowledge and understanding of the Canadian Food and Drugs Act and Regulations, its Policies and related Guidelines, specifically as these relate to Good Manufacturing Practices (GMPs), Good Documentation Practices (GDP) and all GxPs-related expertise.
- Intermediate knowledge of MS Office (Word, Excel and PowerPoint)
- Language proficiency: Written and spoken English and French - Medium level
- Manages the release of biopharmaceutical products and medical devices to the Canadian market per Health Canada requirements, including the management of retained samples and ID testing samples.
- Manages distribution issues that may impact the release of the product.
- Performs change impact assessments of any quality documents identified in the Canadian specification against the product submission.
- Handles the documentation of planned deviations or exceptions report through the AbbVie CAPA system, and manages related tasks, as needed.
- Performs impact assessments of new regulations, policies and guidelines, and manages the revision of related procedures as required.
- Gathers and reviews stability reports and protocols to ensure these are aligned with Health Canada requirements and commitments received and approved by Health Canada under the regulatory submission(s).
- Reviews and prepares the Canadian Annual Product Quality Reviews (APQRs), ensuring compliance with documented timelines.
- Handles GMP-related annual requirements, such as import and confirmatory testing, unique ID letters, etc.
- Handles the change control process through the AbbVie Quality Documentation system for local procedures, Canadian specifications, and other team's related documents.
- Coordinates assigned projects and participates to ad-hoc task forces as needed.
- Ensure key performance indicators (KPIs) are met
AbbVie Inc. St. Laurent Canada
St. Laurant [Canada]