Qualification Engineer

il y a 3 semaines


Beerse, Belgique Arcadis Temps plein

About the Company - We are currently looking for a Qualification Engineer for one of our pharmaceutical clients in the region of Beerse.



About the Role - Qualification support for the Make Asset Management (MAM) group within IM SC Beerse during execution of projects in the Long Range Financial Plan, conform with the applicable work- and RBA methodologies and the execution of the services.


Responsibilities


  • Creating of Project Validation Plan / Report (PVP/PVR)
  • Managing the planning and overview of the Qualification Deliverables in the assigned projects, and reporting in the KANBAN system and towards the engineering lead
  • Creation of Qualification Master Documents (SIA, URS, CARA, TRM etc.) and Qualification Protocols (DQ, IQ, OQ, PQ etc.) and other supporting documents with possibly accompanying templates
  • Writing qualification documentation in KNEAT and securing other related documents on the project folders, TruVault, E-stream
  • Facilitate and Report risk assessment meetings in multi-disciplinary team
  • Review of supplier-related commissioning documentation (FAT, SAT) with regards to leveraging in the qualification stage
  • Support the project team during equipment FAT and SAT at the supplier’s premises
  • Execution and/or reviewing of qualification protocols in KNEAT
  • Attending actively in project (extended) core team meetings


Qualifications - Master in industrial engineering or equivalent by experience


Required Skills - Knowledge of GMP and basic qualification knowledge, Experience with technical documentation, Working independently, Assertiveness, Team player


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