Specialist, Compliance & Documentation, 9 Month Contract - Jobs in Saint-Laurent, QC

Job Description

About AbbVieAbbVie’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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.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 98% of our employees are proud to say they work for AbbVie and 96% 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.Under the management and supervision of the Manager, Quality Assurance Compliance and Documentation (MCD) , the Quality Assurance Specialist, Compliance and Documentation (QASCD) 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 by the Canadian affiliate (AbbVie Canada) are in compliance with 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 Canadian Release Specifications are aligned with specifications filed and approved by Health Canada (i.e., as detailed in the Regulatory submission).
• Handles the Annual Product Quality Reviews (APQRs).
• Handles annual and commitment Stability Testing requirements.
• Handles all GMP related additional annual requirements, such as import and confirmatory testing, unique ID letters, etc.
• Reviews and assess all changes made to GMP related documents such as manufacturing, packaging and testing masters, validation, etc. against specific Regulatory submissions.

In addition, the QASCD is responsible to ensure procedures used are kept up to date and aligned with AbbVie Corporate and Health Canada requirements.Key Responsibilities:

• On a daily basis, using the AbbVie inventory system (SAP), 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.
• On an as-needed basis, as part of the importation process, documents and handles distribution issues that may impact the release of the product.
• Through product release, performs change impact assessments of any quality documents identified in the Canadian specification against the product submission. These documents include manufacturing, packaging, and testing masters, etc.
• As needed, support the Logistic team with the investigation of any inventory discrepancies with our third party warehouses. Type of discrepancies may be on batch quantity, status, expiry dates, etc.
• As needed, work with our third party manufacturer for the management and approval of the over-labeling process.
• On an as-needed basis, handles the documentation of planned deviations or exceptions report through the AbbVie CAPA system, and manages related tasks, as needed.
• Demonstrates scientific judgment, a sound knowledge of regulatory requirements, and a sense of urgency when addressing issues/concerns related to the product audit/release program.
• Performs impact assessments of new regulations, policies and guidelines, and manages the revision of related procedures as required.
• On a daily basis, and as required, provides input and assists MCD on QA-related activities, and keeps the Senior QA Manager (SrMQA) abreast of activities which may impact AbbVie products and/or processes (i.e., negatively or positively).

• Ensure timely documentation review and retention/testing of samples for meeting established release key performance indicators (KPIs) and meet business and commercial requirements.

• 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).
• Gathers data, reviews and prepares the Canadian Annual Product Quality Reviews (APQRs), ensuring compliance with documented timelines. Ensure timely review and approval of the Regulatory Affairs and Quality Assurance senior Managers.
• Handles the change control process through the AbbVie Quality Documentation system for local procedures, Canadian specifications, and other team’s related documents.

• On a daily basis, and through all activities under its responsibility, challenges usual way of performing tasks, and identify continuous improvement opportunities.

• Acts as a back-up to the other Specialists, Compliance and Documentation, as required.
• Supports the QA team, as required

• Coordinates assigned projects and participate to ad-hoc task forces as needed.
• Ensures all GMP-related documentation is available and locally approved against Health Canada requirements. Documentation includes manufacturing, packaging, and testing site validation documents, executed batch review, master product documents, etc.
• On a yearly basis, handles the identification, shipment and review of testing results for the annual confirmatory testing, as required for non-MRA products.
• On a monthly basis, supports the preparation of Documentation related Key Performance Indicators (KPIs) and ensures KPIs are met or exceeded. Keeps MCD and the SrMQA abreast of any issues or concerns.

QualificationsEducation/Experience Required:

• Must hold a science degree B.Sc. (e.g., Biochemistry, Biology, Microbiology, Chemistry, etc.).
• 1 to 3 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
• Initiative and Innovation
• Setting Vision & Strategy
• Integrity
• Organizational skills
• Negotiation Skills
• 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.

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 AbbVie premises (for example, travelling and visiting stakeholders and customers).TravelNoJob TypeExperiencedScheduleFull-timeJob Level CodeICEqual Employment OpportunityAt AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.Quick Apply

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