Description de l'annonce:

1-  Job Summary:

Reporting to the Project Manager, the Project Coordinator is responsible for planning, authoring, executing and maintaining qualification activities for production equipment, product, process and utilities in accordance with the regulatory guidelines, policies and procedures.

2-  Job Responsibilities:

• Lead New Product Introduction or Transfer projects with R&D team.
• Author Installation, Operation, and Performance qualification protocols and reports:

-  Identify the critical parameters and instruments in these protocols and create proper tests.

-  Coordinate the Equipment, Product, Process and Facility Qualification activities as required.

• Support and implement plans to ensure all activities are done within Baxter is compliant to current regulatory requirements.
• Provide training on qualification topics as required.
• Review, initiate and recommend changes, as applicable, to different documents and Validation Master Plan for equipment and facilities qualification.
• Participate in the investigations, the audits and the improvement initiatives.

3-  Job Requirements:

• Bachelor degree in Industrial or Mechanical Engineering.
• Minimum of 2 years’ experience in project management.
• Experience in validations activities and documentations.
• Knowledge of change control and qualification concepts.
• Knowledge of GMP.
• Skills of Microsoft Office software’s (Word, Excel, PowerPoint & Outlook)
• Good command of the English language, both written and verbal.
• Communication skills including verbal, written and presentation skills
• Ability to work effectively in a team based environment
• Problem solving and critical thinking skills.
• Knowledge in statistical techniques and tools.

4-  Preferred Requirements:

• Medical device experience.
• Microsoft Project.
• Minitab.
• Familiarity with Quality System Standards - ISO 9001 and ISO 13485.
• Green Belt certification (or equivalent) would be an asset