QUALITY ASSURANCE ENGINEER

GeelIIndustrie pharmaceutique I Engineering

Description de fonction
  • Will report to the project’s QA Lead.
  • Review and approval of validation / qualification related plans, reports, Impact Assessments, Risk Assessments, Protocols, Test Forms, Deviations, Project Changes for FAT, HAT, SIT, Commissioning, IQ, OQ, PQ focused on software/equipment/process. Ensure Janssen Quality standards and procedures are adhered to.
  • Engaging with Operations, Technical Operations, Software, Equipment, Validation SME’s / project team members in support of progressing / completing the Qualification stages during the migration.
  • Job might rotate to a Validation / Compliance Engineer role during the course of the project.
Profil
  • Degree in Engineering preferred.
  • Pharma experience preferred.
  • Has good interpersonal and communication skills.
  • Has good teamworking skills.
  • Can demonstrate a pro-active behavior, seeing potential issues / risks / opportunities and translate these into mitigations / solutions / improvements.
  • Can work well under pressure.
  • Relevant technical expertise preferred (DCS systems, preferable Emerson DeltaV ; Batch Control ; ISA S88).
  • Knowledge about GAMP 5 preferred.
  • Has GDP/GMP experience and mindset!
  • Fluent in English, Dutch language preferred
  • Has QA experience (equipment/process/E&I/DCS)
  • Has experience with QA related tasks with regards to the Validation of DCS systems on (pharm) equipment & processes, ranging from Validation Master Plan, Impact Assessments, Risk Assessments, URS, FRS, FS, Hardware Acceptance Testing, Site Installation Testing, Software Acceptance Testing, Commissioning & Qualification (IQ, OQ, PQ).
Descriptif de l’organisation et du département

Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium, The Netherlands and Dubai, we provide support to companies who need experienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

Offre

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Avez-vous des questions?
Aartje Huybrechts Select Projects +32 3 612 22 92
QUALITY ASSURANCE ENGINEER Informations offres d'emploi
63058
Ingénieur / Technique
Project sourcing
40
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