Master File Coordinator

4 weeks ago


Montreal, Quebec, Canada Pharmascience Full time

We are seeking a highly skilled Master File Coordinator to join our team at Pharmascience. As a key member of our documentation team, you will be responsible for ensuring the integrity of commercial manufacturing and packaging masters, in accordance with government requirements and customer needs.

Key Responsibilities:

  • Coordinate and provide adequate documentation according to timelines and production needs of Pharmascience sites.
  • Write and approve manufacturing and packaging masters for Pharmascience sites according to approved change controls.
  • Initiate approval or obsolescence cycles and have manufacturing and/or packaging masters approved by authorized persons.
  • Acquire and maintain in-plant expertise for equipment and operational methods in place.
  • Coordinate the implementation of change controls for commercial masters according to established timelines.
  • Process retaining forms and maintain computer tools.
  • Extract SAP production schedules and make masters available for production.
  • Create and maintain finished product specification forms.
  • Collaborate as an expert in resolving documentation issues and answer questions from internal customers.

Requirements:

  • Strong knowledge of GMP and effective regulation.
  • Ability to effectively manage time and multiple priorities.
  • Sharepoint, SAP, and TOPSPRO software knowledge, an asset.
  • Excellent communication and problem-solving skills.

Working Environment:

The work takes place mainly in an office environment, in front of a computer. Factory and warehouse presence is frequently required. The employee must follow good manufacturing and health and safety practices at all times.



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