Specialist, Quality Assurance

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**:

- Normal Office Conditions: Yes
- Evening/Weekend commitments: No
- % travel required: 5 %
- Location Montreal (Québec), Canada