Specialist, Quality System

6 months ago

Montréal, Canada Centre de production de produits biologiques Inc Full time

The Biologics Manufacturing Center ( BMC ) Inc. is a new biomanufacturing facility created in response to the pandemic. A not-for-profit organization, the BMC aims to better meet the biopharmaceutical needs of Canadians. The BMC helps support projects of public interest, actively contributes to the overall growth and resilience of the Canadian life sciences industry, and fosters industry development and innovation through Canadian production. Backed by a committed and innovative team of employees, the BMC fosters a culture of agility and transparency, with a collaborative, results-oriented approach.

We are looking for a **Quality System Specialist - Validation** who will be responsible for monitoring the quality of all validation activities and their supporting requirements throughout the product life cycle.

Reporting to the Manager, Quality Assurance, the **Quality System Specialist - Validation** will be responsible for:

- Evaluate validation documents to ensure that regulatory requirements are integrated into the documentation, and that test scripts define precise acceptance criteria reflecting the requirements (URS) for execution in accordance with procedures, specifications and GMP requirements and expectations.
- Approve validation protocols before and after execution.
- Review and approve deficiencies encountered during execution of validation protocols.
- Review and approve engineering and validation documents such as drawings, user requirements and functional specifications (URS, UFS or UFRS), configuration specifications (CS), design specifications (DS), data integrity assessments (DI), asset introduction forms, calibration, and maintenance profiles, etc.
- Support Data Integrity (DI) initiatives and provide guidance for remediation.
- Participate in automation initiatives and the implementation, transition, or migration of GMP computerized systems.
- Act as a quality resource for stakeholders in the validation process and related GMP activities.
- Provide support and expertise during quality event investigations and change controls.
- Promote a culture of quality throughout the site and in all its departments.

**Does this position match your career aspirations? We would like to receive your CV if**:

- You have a bachelor’s degree in a scientific discipline such as engineering, biochemistry or microbiology.
- You have at least 5 years' experience in quality assurance in the pharmaceutical industry, including at least 2 years in validation.
- You understand validation processes and have direct experience with data integrity.
- You can express yourself in French or are committed to taking French courses.
- You can understand and review technical documents in English from out-of-province suppliers for customers and regulatory agencies.
- You live in the province of Quebec.

**The BMC, an employer offering what's important to you.**
- A flexible schedule and work mode.
- A culture of transparency, notably with our monthly corporate meetings
- A respectful and friendly work environment
- A new building with state-of-the-art equipment
- A competitive salary commensurate with your skills
- An attractive vacation and leave program
- A group RRSP with a generous contribution from the BMC
- A comprehensive insurance plan including telemedicine
- An opportunity to participate in our various life committees (social club, employee committee, OHS committee, etc.)
- A host of activities throughout the year to socialize with your colleagues, recognize team successes and improve your knowledge.
- Free on-site parking.

**The BMC, an organization like no other**
- Our team is made up of talented, committed individuals with diverse backgrounds.
- We aim to develop, share and transmit knowledge
- Our NPO status enables us to reinvest every dollar of profit back into the organization
- Our human scale empowers all our employees to participate in driving the company forward
- Our economic positioning is unique in our industry
- Our social mission is extraordinary

**The BMC, a key player in Canadian biotech production**

The BMC is a new facility in the heart of Montreal, completed in June 2021. It supports the growth of the country's biologics production capacity, ensuring that vaccines and other related products can be manufactured safely, right here at home. Thanks to its state-of-the-art facilities and the knowledge of its team, the BMC can produce biopharmaceutical products such as viral vector, protein subunit and virus-like particle vaccines, as well as other biological products. It is a key player in Canada's ability to respond rapidly to future national and global health emergencies.

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