Specialist, Quality System

Contenido de trabajo

The Biologics Manufacturing Centre (BMC) Inc. is a new 54,900 square foot biomanufacturing facility whose construction was completed in June 2021. The BMC, a not-for-profit organization, supports the expansion of Canada’s biologics manufacturing capacity, ensuring that vaccines and other related products can be safely manufactured at home. BMC is designed to produce biopharmaceuticals such as viral vector, protein subunit and virus-like particle vaccines and other biologics.

In order to contribute to the implementation of the new not-for-profit organization and to make biomedical innovations more accessible to Canadians, we are looking for a Quality System Specialistwho will support the activities of the quality assurance department.

Under the supervision of the Quality Assurance Manager, the Quality System Specialist will be responsible to:

• Provide expertise on technical documents from a quality point of view and approve all related documentation at each stage of the life cycle (URS, FAT, commissioning, qualification, validation) of installations, utilities, system applications, equipment, cleaning, process, and analytical methods.
• Evaluate and approve deficiencies encountered during the execution of qualification protocols.
• Define and ensure the maintenance of data integrity throughout the site.
• Support investigations and the management of quality systems.
• Monitor the analytical method transfers from quality assurance perspective (feasibility, verification and qualification).
• Act as a resource person from a quality perspective for all parties involved in the qualification process, and for all employees involved in activities related to Good Manufacturing Practices (GMP).

You are the person we are looking for if:

• You have a minimum of a Bachelor’s degree in science.
• You have a minimum of five (5) years’ work experience in a similar quality assurance role in the biopharmaceutical/ pharmaceutical GMP industry or equivalent, including a significant experience in equipment qualification/validation, computer systems, analytical methods.
• A combination of relevant education and experience may be considered.
• You have in-depth knowledge of pharmaceutical industry quality standards, regulations and guidelines.
• You have the ability to work with multiple documents of a complex nature and to cross-reference them in order to get a global view.
• You are client and result oriented, collaborative, have good communication skills and a strong sense of organization and priority management.

What we offer:

• A respectful and friendly work environment in a new facility with state-of-the-art equipment ;
• A competitive salary commensurate with your skills;
• Attractive time off allowances;
• A complete range of benefits: group insurance, telemedicine, group RRSP and EAP;
• Possibility of teleworking in hybrid mode;
• On-site parking.

Job Type: Full-time

Schedule:

• Monday to Friday

Work Location: In person