Supervisor Manufacturing, Documentation

2 months ago

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

**Supervisor Manufacturing, Documentation**

The Biologics Manufacturing Center (BMC) inc. is a new bio-manufacturing facility whose construction was completed in June 2021. As a not-for-profit organization having a public interest mandate, BMC is a key player in Canada's ability to respond rapidly to future national and global health emergencies. In addition, BMC supports 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. Designed to manufacture biopharmaceuticals such as viral vector, protein subunit and virus-like particle vaccines, as well as other biologics, BMC is helping to increase domestic biomanufacturing capacity, ensuring that vaccines and other biologics can be made safely in Canada, for Canadians. With its committed and innovative employees, BMC fosters a culture of agility and transparency with a collaborative, results-oriented approach. Join us in supporting the public health of Canadians

We are looking for a **Supervisor Manufacturing, Documentation** who will be in charge of all Good Manufacturing Practice (GMP) manufacturing documentation. Along with their team, they will lead documentation processes from a manufacturing standpoint, including investigations, CAPA and change controls. They will also own, update, and maintain all standard operating procedures, work instructions and Master Batch Record (MBR) documents.

Reporting to the Director, manufacturing, the **Supervisor Manufacturing, Documentation** will have the following responsibilities:

- Supervise, establish priorities, organize, monitor, manage performance and provide mentorship to team members.
- Provide the Manufacturing department with technical writing capabilities along with enhanced GMP support.
- Lifecycle management of all documentation in Document Management System (DMS) for Manufacturing.
- Supervise the creation and update of master batch records, standard operating procedures, work instructions and forms.
- Supervise/support drafting and investigating of deviations using root-cause-analysis.
- Actively involved with Quality Events (QE): CR, CAPA, and Work Order (WO) management including their closure in a timely matter.
- Manage from end-to-end CAPA and CR process for production - creation, evaluation, planning, execution, and development and implement strategies to mitigate identified risks.
- Create and update quality metrics for manufacturing Quality Management System (QMS), CAPA, CR, and QE to track and monitor the timely completion of QMS tasks.
- Update, monitor and control required manufacturing related GMP records which include MBRs, executed Batch Production Records (BPR), SOPs, WIs, Forms and logbooks.
- Initiate and foster good communication and collaboration with cross functional teams including Quality Assurance, Quality Control, Validation, Supply Chain, and Maintenance to ensure unified assessment/action.
- Continuously review and optimize compliance and documentation processes and provides feedback.
- Prepare and maintain documentation for regulatory inspections.
- Maintain up-to-date training records of manufacturing team members.
- Recruit, orient and train new employees for their team.
- Recruits, orients coaches and trains personnel.

**You are the person we are looking for if**:

- You have a college diploma in Life Sciences (biotechnology, engineering, etc.)
- You have at least five (5) years of experience in supervising GMP pharmaceutical or biopharmaceutical manufacturing operations.
- You have significant experience with manufacturing documentation, including investigations, change control, MBR and BPR.
- You have excellent understanding and knowledge of bioprocessing and GMP operations and quality standards, regulations and industry guidelines.
- You have the ability to accurately interpret technical direction from a variety of sources as well as create, review and revise SOPs, work instructions, and processes.
- You have excellent interpersonal skills and ability to communicate effectively both orally and in writing and interface with external and internal groups.
- You are quality and results oriented, have a great sense of collaboration, organization, autonomy 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;
- On-site parking.

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