Specialist, Quality Assurance - Montréal, Canada - Lundbeck

Lundbeck

Verified Company

Montréal, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

We are currently looking for a qualified Specialist, Quality Assurance to join the Lundbeck Canada Quality Assurance team. This position is permanent full-time located at our Ville Saint-Laurent head-office. The incumbent will report to the Senior Director, Quality Operations US.

Lundbeck Canada offers comprehensive benefits to its employees, including health and dental benefits and contribution to a pension plan as of day 1.

Your Position:

The Quality Assurance Specialist is responsible for overseeing, coordinating and implementing designated quality projects and activities. Responsibilities include quality approvals and maintenance of the quality systems.

Management of Quality Assurance Projects (35%)

Ensure that the marketed drugs comply with GMPs and Health Canada regulations as it relates to small molecule and biologics.
Support all Quality Assurance system revisions and updates.
Support continuous improvement projects as required and assigned.
Participate and execute on inspection readiness initiatives
Contribute in the closure of any relative Quality or Compliance related gaps within the site or systems.

Quality Assurance Systems (40%)

Responsible for GMP documentation review and release, repackaging, returns, and Product Quality complaints of the Canadian marketed products.
Perform and approve visual inspection of the Canadian finished products.
Review Master Documentation for all Canadian marketed products/formats.
Compile, maintain and evaluate formal and ongoing Stability Data related to Canadian products.
Review and evaluate the Product Quality Reports (PQR) related to Canadian products.
Initiate, review and approve the quality complaints received from customers, evaluate related investigations; prepare and approve Canadian responses to clients.
Initiate, review and approve storage and distribution complaints associated to marketed products.
Participate in the verification of the monthly counts generated by the Sales Force for the Physician, and or relevant donation samples.
Contribute to the maintenance of the Quality Agreements with vendors and service providers.
Write and edit Quality SOP's; align procedures with Regulations, and Corporate requirements.
Participate and support development and GMP Overview training for all employees involved in GMP activities.
Participate in the redaction of the distributor Client Manual.
Participate in the update and renewal of the Establishment Licence.

Professional and GMP Support to Internal and External Customers (20%)

Participate in Regulatory Affairs and Quality Assurance meetings, and work in accordance with Lundbeck strategy.
Maintain positive and productive collaborations with internal departments, consultants, regulatory agencies to discuss and resolve various issues or questions during and between audits.
As required, assist Regulatory Affairs Managers with the QA data needed for submissions to Health Canada.
Provide GMP expertise and recommendations to different departments at Lundbeck Canada Inc.
Maintain a Collaborative relationship with Headquarters in Denmark, to ensure support for Canadian GMP systems and timelines.

Professional Development (5%)

Plan, invest time and energy into individual professional development.
Maintain up to date knowledge of Canadian and European GMP requirements.

Position Qualifications:

Bachelor's degree in Biology or Biochemistry.
Minimum of (3) years of experience in similar positions, in Quality Assurance within the Canadian pharmaceutical industry
Knowledge of Biopharmaceutical manufacturing and or Quality oversite (an asset).
Knowledge and understanding of Canadian regulations as it applies to small molecule (required) and Biologics (an asset)
Knowledge of European and US regulations (an asset).
Bilingualism (French & English), oral and written
High proficiency in Windows 10 and Microsoft Office 2010

Working Conditions: