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Open nowPosted 49 days ago

Qualification d'Équipements & CSV Specialist

job-room.ch88,617 open roles

Where
Lausanne, VD, Switzerland
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Your applicationOpen nowQualification d'Équipements & CSV Specialistjob-room.ch · Lausanne, VD, Switzerland

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on job-room.ch's own form.

The reply lands in your private mailbox

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The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market. job-room.ch postings stay open a median of 2 days.

Share of postings closed within
  1. 1.7%1 day
  2. 3.5%3 days
  3. 7.8%7 days
  4. 14.6%14 days
  5. 34.1%30 days
This job: posted 49 days ago

job-room.ch median: 2 days open

The posting

  • Prenez part à l'intégration d'un équipement automatisé stratégique.
  • Pilotez les activités de qualification et d'exécution des tests.

About Our Client ##

Notre client est un acteur international reconnu du secteur medtech, engagé dans l'innovation et l'excellence opérationnelle. Son environnement stimulant offre l'opportunité de participer à des projets industriels à forte valeur ajoutée dans un contexte qualité exigeant.

Job Description ##

  • Participer aux activités de qualification liées à l'intégration d'une ligne d'inspection visuelle automatisée.
  • Réviser et approuver les protocoles de SAT.
  • Réviser et approuver les rapports de SAT.
  • Rédiger les protocoles de qualification IQ, OQ et PQ.
  • Exécuter les tests de qualification conformément aux protocoles approuvés.
  • Rédiger les rapports de qualification et assurer la traçabilité documentaire.
  • Identifier, documenter et investiguer les écarts détectés durant les phases de qualification.
  • Coordonner les actions correctives et suivre la résolution des écarts.
  • Garantir la conformité des activités avec les exigences GMP et les standards qualité applicables.
  • Participer aux activités de validation des systèmes informatisés embarqués.
  • Veiller au respect des principes de Data Integrity et des exigences 21 CFR Part 11.
  • Collaborer étroitement avec les équipes qualité, ingénierie, automatisation et fournisseurs.

The Successful Applicant ##

  • Formation supérieure en ingénierie, sciences de la vie ou discipline similaire.
  • 5 à 10 ans d'expérience en qualification d'équipements et validation dans un environnement pharmaceutique ou dispositifs médicaux.
  • Solide expérience sur des lignes automatisées complexes et équipements industriels intégrés.
  • Maîtrise de la rédaction et de l'exécution de protocoles IQ/OQ/PQ.
  • Expérience concrète dans l'exécution de tests de qualification sur le terrain.
  • Bonne connaissance des systèmes informatisés embarqués et de leur validation.
  • Bonne connaissance de la réglementation 21 CFR Part 11.
  • Expérience dans la gestion, l'investigation et la résolution des écarts.
  • Capacité à travailler de manière autonome et proactive.
  • Excellentes aptitudes rédactionnelles en français et en anglais.
  • Esprit d'analyse, rigueur et orientation résultats.

What's on Offer ##

  • Une mission temporaire pour apporter son expertise.
  • Participation à un projet d'automatisation stratégique dans un environnement international et innovant.
  • Forte visibilité, autonomie et collaboration avec des experts qualité, validation et ingénierie.

Quote job ref

JN-082026-7083817

Job Function

Engineering & Manufacturing

Specialisation

Quality

Industry

Healthcare / Pharmaceutical

Where

Lausanne Region

Contract Type

Interim

Job Reference

JN-082026-7083817

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