AbbVie QA Specialist, Compliance and Documentation in St. Laurent, Canada
QA Specialist, Compliance and Documentation
Canada, Quebec, St. Laurent
2 additional locations
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.
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 for the maintenance of procedures used as part of its job responsibility to ensure they are kept up to date and aligned with AbbVie Corporate and Health Canada requirements. Equally, QASCD acts as system administrator and key Affiliate contact for the AbbVie training system (ISOTrain).
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, works with the AbbVie third party partner for the management and approval of the over-labeling process and other related activities.
On an as-needed basis, handles the documentation of planned deviations or exceptions report through the AbbVie CAPA system, and manages related tasks.
Responsible for the assignment of training to employees in ISOtrain, for the maintenance of the QA training matrix, and for the reconciliation of late training events.
When delegated, 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).
On a regular basis, reviews the listing of annual and commitment stability studies. Gathers and reviews 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).
Ensure timely documentation review and retention/testing of samples for meeting established release key performance indicators (KPIs) and meet business and commercial requirements.
As per the procedure, 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.
As needed, supports the Compliance and Documentation team in the gathering and the preparation of the Yearly Biological Product Review submissions (YBPR).
Handles the change control process through the AbbVie Quality Documentation system for local procedures, Canadian specifications, and other QA team related documents.
As needed, acts as a back-up to the other QASCD and to the Senior QA Specialist, Compliance and Documentation
Coordinates assigned projects and participate to ad-hoc task forces as needed (ex: provides support with technical documentation to Quality Assurance Managers, supports Health Canada or AbbVie Corporate audits, etc.)
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.
Strong interpersonal skills/Team Player
Initiative and Innovation (i.e. challenges usual way of performing tasks, and identify continuous improvement opportunities).
Organizational and Time Management skills, sense of urgency (i.e. demonstrates scientific judgment and a sense of urgency when addressing issues/concerns related to the daily tasks or ad-hoc critical business situations).
Communication Skills (Verbal and Written) with Internal and External Customers (e.g., Health Canada, AbbVie Global).
Ability to work with minimum supervision
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.
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.
Advanced knowledge of SAP, SOLTRAQs, Vivaldi, Attaché, ISOTrain
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.
English and French must be at advanced level, oral and written.
AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.
Posting End Date: April 30, 2019
Job Type: Experienced