Quality Assurance Specialist, Compliance and

3 weeks ago

SaintLaurent, Canada ABBVIE Full time

Joining AbbVie means, you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada whereby 92% of our employees are proud to say they work for AbbVie.

When choosing your career path, choose to be remarkable.

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health, in addition to products and services across its Allergan Aesthetics portfolio.

Under the management and supervision of the Manager, Quality Assurance Compliance and Documentation the Quality Assurance Specialist is responsible for ensuring that requirements for all activities related to the importation and the release on the Canadian market of biopharmaceutical products and medical devices distributed follow Health Canada’s Good Manufacturing Practices (GMP) and relevant AbbVie Corporate policies. These activities include, but are not limited to, the following:

- Maintains an in-depth knowledge and understanding of current GMP and Medical Device-related Health Canada regulatory requirements and guidelines.
- Ensures that release specifications are aligned with specifications filed and approved by Health Canada.
- Handles annual and commitment stability testing requirements.
- Handles GMP-related annual requirements
- Reviews and assess all changes made to GMP-related documents such as manufacturing, packaging and testing masters, validation, etc.

**Key Responsibilities**:

- 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

**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.

**Essential Skills & Abilities**:

- 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

AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.

**Covid vaccination new hires amendments**:
Full vaccination against COVID-19 is a condition of employment for this position, with possible accommodation for validated exemptions, within the limits of applicable legislation. AbbVie employees are also required to comply with any COVID-19 related external requirements, including any testing requirements, applicable to their work activities outside Ab

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