Specialist Manufacturing, Documentation

2 weeks ago

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

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 CanadiansThe BMC is looking for a **Specialist Manufacturing, Documentation** who will use his advanced knowledge in production and Good Manufacturing Practices (GMP) to support the quality activities of the Manufacturing team and projects related to the production.Under the supervision of the Director of manufacturing, the **Specialist Manufacturing, Documentation** **will have the following responsibilities:
- Create, draft, review and update production documentation: batch production record (BPR), work instruction (WI), standard operating procedure (SOP) based on corrective and preventive actions (CAPA), change control requests (CCR), and coordinate with other units the programming of training related to changes;
- Follow up on the resulting CAPAs that are defined as part of an investigation or continuous improvement, facilitating the completion of the necessary activities by stakeholders to ensure that actions are closed on time;
- Initiate, investigate, perform root cause analysis, and determine corrective actions for production related deviations;
- Manage CCR from end to end - write, present to the evaluation committee, follow up of evaluations, create of require actions, follow-up and closure of actions - which are defined following a CAPA or a continuous improvement project or for the modification of SOPs, BPR, logbooks and work instructions;
- Proactive contribute to quality control activities and their documentation from a GMP perspective;
- Play a key role in the initial, ongoing and strengthening training of GMP with Technologists Manufacturing;
- Support on key projects for production - introduction of a new equipment (CR, validation support), data integrity, etc.;
- Support for the review of production documents - i.e. logbook, BPR, etc;
- Support the implementation and maintenance of the data integrity management program in manufacturing.

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

- You hold at least a college diploma in life science/biotechnology or other appropriate discipline;
- You have three (3) years of experience in the pharmaceutical industry, in production and in a GMP role. Experience with vaccines is strongly preferred;
- You have knowledge of data integration management and IT system validation programs and an experience would be an interesting asset;
- You have a talent for writing procedures, batch records, detailed and clear protocols;
- You are customer-oriented, have good communication skills, a good spirit of collaboration and a great 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 aligned with your skills;
- Attractive vacations allowances;
- A full range of benefits: group insurance, telemedicine, group RRSP and EAP;
- Teleworking;
- On-site parking.

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