Quality Assurance Specialist

3 months 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 90% of our employees are proud to say they work for AbbVie and 88% are proud of how we contribute to the community.

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, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

When choosing your career path, choose to be remarkable.

The Commercial Quality Specialist is responsible for independently providing Commercial Quality support in the affiliate. Scope of activities includes quality system requirements associated with: pharmaceutical products, medical devices, combination products, biologics and cosmetics. Specific areas of support may include Storage and Distribution, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This position will ensure that all product, process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate, governmental, and local regulations and requirements.

**Responsibilities**:

- Responsible for the integration of local quality regulations for drugs, biologics, device and/or combination products and cosmetics.
- Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
- Work on assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
- Plan, prepare, review, and approve quality documentation such as change controls, product reviews and other local requirements.
- Support self-inspections, internal, external and MoH audits as directed by the manager.
- Coordinate and investigate quality events such as deviations, non-conformances and corresponding action plans including decisions.
- Execute supplier qualification program including performance monitoring for key suppliers.
- Monitor metrics and KPIs to ensure compliance.
- Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
- Support the Management Review process for the affiliate.
- Represent Commercial Quality in cross functional teams, projects and programs, as assigned by management.
- Bachelor’s degree in chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
- 2+ years experience in quality assurance, GMP or GDP environment preferred.
- Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire and OneVault.
- Full understanding of local GxP requirements including regulations and standards affecting device, biologics, pharmaceutical products and cosmetics.
- General knowledge and understanding of AbbVie MD, pharmaceutical, biologic and cosmetic products and regulations
- Ability to support projects as a team member as assigned by manager
- Experience working in both a team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Make decisions in collaboration with management
- Acts as an owner - uses available resources to independently complete assigned tasks

AbbVie strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the following requirement, **advanced amount of knowledge of English / Fluency in English** is an essential requirement for the position of **QA Specialist **including, but not limited to, for the following reasons:

- English speaking employees outside the province of Quebec.
- English speaking clients outside the province of Quebec.
- Anglophone region outside the province of Quebec.

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

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