QA VALIDATION ENGINEER

mechelenIIndustrie pharmaceutique

Description de fonction

QA VALIDATION ENGINEER (process & equipment)

  • The function holder will be present on the operational shop floor
  • Quality oversight of cartridge materials handling (warehouse, handling of materials non conformities, qualification of new materials and changes to existing materials)
  • Quality oversight on development and commercial cartridge manufacturing activities (Review of cartridge manufacturing batch records, handling of process non conformities, follow up of CAPA’s, assessment of process change request, performance quality reviews and trending).
  • Quality oversight on cartridge stability studies
  • Quality oversight on equipment qualification, process validation, changes to equipment, introduction of new equipment
  • Quality oversight on new product introduction
  • Quality oversight of incoming cartridge materials handling (warehouse, handling of materials non conformities, qualification of new materials and changes to existing materials initiated by the supplier)
  • Quality oversight on cartridge manufacturing activities at the supplier (handling of process non conformities, follow up of CAPA’s, assessment of process change request)
  • Quality oversight on suppliers used for manufacturing of cartridge parts and components (follow up and approval of supplier qualification documentation)
  • Quality oversight on equipment qualification, changes to equipment, introduction of new equipment at the supplier
Profil

As Validation equipment engineer you have / are :

  • Bachelor level in quality or process engineering or equivalent by experience
  • Preferably 5 years of experience in the function of QE operations in an IVD - MD manufacturing environment, or equivalent experience
  • Advanced knowledge, orally and in writing, of Dutch and English
  • Result oriented and driven
  • Team player and eager to learn
  • Flexible and pro-active mindset
  • Can work autonomously
  • Well-developed interpersonal skills
  • Analytical mindset
Descriptif de l’organisation et du département

Select Projects maakt deel uit van een internationale full-service Human Resources-organisatie, Select HR. Select Projects is specialist in het aanbieden van oplossingen via projectsourcing. Vanuit onze vestigingen in België en Dubai bieden wij ondersteuning aan bedrijven die behoefte hebben aan ervaren specialisten/projectmedewerkers in verscheidene werkgebieden. We onderscheiden ons door onze goede opvolging en service naar al onze klanten en onze medewerkers.
Voor één van onze pharma klanten in Mechelen zijn wij op zoek naar een QA VALIDATION ENGINEER (process & equipment)

Offre

Je krijgt een aantrekkelijk salarispakket met interessante extralegale voordelen, dit alles in een boeiende werkomgeving waar je volop de mogelijkheid hebt om je te ontplooien en verder te ontwikkelen

Avez-vous des questions?
Aartje Huybrechts Select Projects +32 3 612 22 92
QA VALIDATION ENGINEER Informations offres d'emploi
62633
Ingénieur / Technique
Project sourcing
40
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