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Master File Coordinator

3 months ago

Montreal, Quebec, Canada Pharmascience Full time

We are currently seeking a Master File Coordinator. The chosen candidate will operate on a schedule from 10 a.m. to 6 p.m. to ensure optimal availability for our operations.

Key Responsibilities

  • Ensure the integrity of commercial manufacturing and packaging masters, adhering to regulatory standards and client requirements.
  • Oversee the creation and accuracy of packaging masters for research and development projects.
  • Develop in-plant expertise related to the equipment and methodologies necessary for the approval of manufacturing masters.
  • Coordinate and provide necessary documentation in alignment with the timelines and production demands of Pharmascience to uphold quality and customer service standards.
  • Lead continuous improvement initiatives and manage changes within the documentation team according to established timelines.
  • Keep procedures and work instructions current and relevant.
  • Represent the documentation sector in operational meetings.
  • Contribute expertise to operational projects.

Documentation Management

  • Draft and approve manufacturing and packaging masters for Pharmascience sites in compliance with approved change controls.
  • Initiate and oversee the approval or obsolescence processes for manufacturing and packaging masters as per established procedures.
  • Gather feedback from plant personnel regarding changes to masters as necessary.
  • Maintain in-plant expertise in line with existing equipment and operational methods.
  • Facilitate the implementation of change controls for commercial masters, ensuring adherence to timelines and monitoring progress.
  • Process retention forms upon receipt and maintain the associated computer tools through follow-ups with initiators.
  • Analyze the SAP production schedule weekly to assess retained masters, liaising with initiators to ensure availability for production.
  • Create and manage finished product specification forms for items packaged at Pharmascience sites.
  • Act as a resource in resolving documentation challenges and respond to inquiries from internal stakeholders regarding manufacturing and packaging masters.
  • Maintain the software used for master management.
  • Utilize TOPS PRO to diagram the packaging configuration of products.

Recipe Management

  • Request the creation or modification of Bills of Materials (BOM) in collaboration with the Info-Recette group.

Continuous Improvement

  • Develop and maintain procedures specific to the Master group.
  • Participate as an expert in continuous improvement projects and interdepartmental meetings.
  • Stay informed about processes and documentation in accordance with regulatory requirements.
  • Coordinate the execution of continuous improvement projects and their implementation within set deadlines.
  • Conduct integrated testing when implementing changes to IT tools.
  • Perform additional tasks as assigned by the immediate supervisor.

Systems Management

  • Act as a contributor and Master Coordinator in Opentext (DMS).
  • Manage change control actions in Trackwise (QMS).
  • Access employee resources in SuccessFactor (LMS).
  • Contribute to the Documentation site on Sharepoint.
  • Utilize TOPSPRO effectively.
  • Have read-only access to SAP.

Designated Backup for the Following Positions

  • Master File Specialist (Master Section)

The role primarily involves working in an office environment, with frequent requirements to be present in factory and warehouse settings. Adherence to good manufacturing practices and health and safety protocols is essential at all times.

Required Skills and Qualifications

  • Strong observational skills, attention to detail, analytical and synthesis abilities, problem-solving aptitude, and a proactive approach.
  • Thorough understanding of Good Manufacturing Practices (GMP) and relevant regulations.
  • Ability to manage time effectively and prioritize multiple tasks.
  • Familiarity with Sharepoint, SAP, and TOPSPRO software is advantageous.