Contracting - Rixensart 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 Jefferson Wells offers you a permanent contract as a consultant wi... FDA, Universities, Expertise, GMP, Autoclaves, Risk Analysis, Science, Bioprocessing, Protocols, Vaccine, ECC, Master Data, Document management, Validation, Supply chain, Projects, Coordination, Planning, VOS, EMEA, Quality Control, Control Management, SIP, Production, Formulation, Change Control, Quality assurance, Change Management, CAPA, Filling, Process control, Automation Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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