Master File Coordinator – Pharmascience

Title of the Job: Master File Coordinator

Location: Montreal, QC

Job Description: Description :We are presently looking for a Master File Coordinator. The selected candidate will be working on the 10 a.m. to 6 p.m. schedule as we need to offer a larger availability for the operations.Tasks & Responsibilities

• Responsible for the integrity of commercial manufacturing and packaging masters, in accordance with government requirements, in addition to requirements from customers and Pharmascience.
• Responsible for the creation and integrity of packaging masters for research and development.
• Acquire and maintain in-plant expertise for the equipment and methods required for production approval of manufacturing masters.
• Coordinate and provide adequate and available documentation according to the timelines and production needs of Pharmascience sites in order to maintain the level of quality and customer service required by the company.
• Coordinate continuous improvement projects or other changes according to timelines for the documentation team.
• Maintain procedures and work instructions up to date.
• Responsible for representing the documentation sector at operational meetings.
• Contribute as experts to operational initiatives.

DOCUMENTATION

• Write and approve manufacturing and packaging masters for Pharmascience sites according to approved change controls.
• Write and approve packaging masters for research and development.
• Initiate approval or obsolescence cycles and have the manufacturing and/or packaging masters approved by authorized persons according to the procedures in place.
• Obtain feedback from plant employees for changes made to masters when needed.
• Acquire and maintain the in-plant expertise according to the equipment and operational methods in place.
• Coordinate the implementation of change controls for commercial masters according to established timelines and by monitoring and closing change control actions according to established dates.
• Process the retaining forms upon receival of the associated form and maintain the computer tool by following up with the initiators
• Extract the SAP production schedule each week to analyze the retained masters, then contact the initiator of the retaining request, then make the masters available for production.
• Create and maintain finished product specification forms for products packaged at Pharmascience sites.
• Collaborate as an expert in resolving documentation issues and answer questions from internal customers regarding manufacturing and packaging masters.
• Represent the documentation sector at operational meetings.
• Maintain master’s management software.
• Diagram the packaging configuration of a product using TOPS PRO.

RECIPE

• Make the request for creation and / or modification of BOM (Bill of Materials) with the Info-Recette group.

CONTINUOUS IMPROVEMENT

• Responsible for creating and maintaining the procedures specific to the Master group.
• Collaborate as an expert on continuous improvement projects and interdepartmental meetings.
• Maintain current knowledge of processes and documentation according to government regulations.
• Coordinate continuous improvement projects and their implementation according to the prescribed deadlines.
• Perform integrated tests when changing IT tools.
• Perform all other tasks assigned by his immediate superior.

SYSTEMS

• Contributor and Master Coordinator in Opentext (DMS)
• Assignee for change control actions in Trackwise (QMS)
• Employee access in SuccessFactor (LMS)
• Sharepoint contributor for the Documentation site
• User in TOPSPRO
• SAP Read Only Access

DESIGNATED REPLACEMENT FOR THE FOLLOWING POSITIONS

• Master File Specialist (Master Section)
• The work takes place mainly in an office environment, in front of a computer. Factory and warehouse presence ise frequently required.
• The employee must follow good manufacturing and health and safety practices at all times.

Skills, knowledge and abilities

• Sense of observation, thoroughness, rigor, ability to analyze and synthesize, problem-solving skills, action-oriented, knowledge of processes and potential impacts.
• Very good knowledge of GMP and effective regulation
• Ability to effectively manage time and multiple priorities
• Sharepoint, SAP and TOPSPRO software knowledge, an asset

Education : BachelorExperience : 1 years: in a similar role within the pharmaceutical industry

Company Name: Pharmascience

Salary:

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