Qualification Engineer
il y a 3 semaines
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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