freelance
Project Manager Medior Reference number: 339
Published: 13-06-2018, 10:32
Region: Lessines
Sector: Pharma
Start: 25 Jun 2018
Job description
• Project management for the implementation R&D project
o Creation of a multi-departmental team and coordination of activities and information
o Creation and follow up of a planning for the project to ensure that the defined milestones are met
o Organization and coordination of project activities (including post-implementation activities like training and improvements)
o Define the most efficient way to integrate the new product into manufacturing
o Definition and Follow up of project budget
o Support coordinate activities related to
• NDA Files preparation, FDA approval (if applicable)
• Pharmaceutical development (USP) – RM & FP analytical methods transfer management
• Sterility development: cycle qualification according to US/EU requirements
• Stability, Clinical Batches production and release
• FOC production and release
o Reporting to global and local program team
• Project documentation
o Creation of project documentation with the team (CCR, URS, FS, DS, RBLCM…)
o Follow up of validation activities and documentation
o FOC documentation
Required Skills
  • At least 2 years in Project Coordination within an R&D / Manufacturing environment
  • English fluent
  • Personality: resilient, energetic and positive attitude
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