Project Manager Validation
Your 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, isolator…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 eCC or projects
• Review and approve protocols and reports and
check-lists and risk assessment related to validation
• Manage deviations and out of specifications and CAPAs : bring expertise and
help in investigating and solving issue
Manage documentation SOP/ OF and master data needed for the project
Your profile ?
Basic qualifications:
– University degree in sciences
– Validation
– Change control management
– At least 3 years experience in Supply Chain activities (production,
– QC, QA, Validaton) in a global environment.
– GMP knowledge
– Knowledge of regulatory
– Knowledge of Bio processes
– Knowledge of Bio vaccines
Preferred qualifications:
• Validation expertise
• Change management
• eCC expertise
• P&P or similar experience/expertise
