Project Coordinator
Wavre – Contracting
The responsibilities
• Responsible for the coordination of the validation of small projects linked to eCC Secondary (Formulation or Filling) related to equipment such as freeze dryer, autoclaves, oven…or CIP, SIP, Mediabulk, Mediafill, Mediaform or utilities (EDI, EPI, EUF, VP, ACP, N2) or process control/automation equipment.
• Responsible for defining and implementing an adequate validation strategy in compliance with FDA, EMEA and International quality standards.
• Responsible for ensuring and coordinating the support (planning, weekly validation, resources, cost) to RPCs or projects.
• Review and approve protocols and certificates for IQ/OQ/PQ and check-lists.
• Manage deviations and out of specifications: bring expertise and help in investigating and solving issues.
• Ensure correct and state of the art Validation approaches for eCC from Design Qualification step to the establishment of the Qualification Summary report (which is final approved by the QA). This accountability involves knowledge of the Validation Life-cycle process as well as in Specific Validation Strategies (i.e.Cleaning Validation, Aseptic Media Simulation…)
• Responsible for assuring inspection readiness – regarding Validation – by Corporate functions and RA authorities (FDE,EMEA,Canada). Make sure that drawings and core files are updated.
• Has developed at least one area of expertise and is recognized as such.
• Bring expertise and coaching to streams
• Project Management: control/monitor cost and planning. Take corrective actions if necessary.
• Ensure coordination with all key players (local QA, Global QA,
• C&M, Streams rep…)
The skills and Knowledge Requirements
Must Haves:
– University degree in sciences
– Validation
– Change control management
– At least 5 years’ experience in Supply Chain activities (production,
– QC, QA) in a global environment.
– GMP knowledge
– Knowledge of regulatory
– Knowledge of Bio processes
– Knowledge of Bio vaccines
Nice to haves:
• Green belt or project management certification is an asset
• Validation expertise
• Change management
• eCC expertise
• P&P or similar experience/expertise.
Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
