Associate QA

Doorsturen
 
  • Aanbod Max. € 50,000
  • Functiegroep Logistics, Manufacturing
  • Dienstverband Fulltime
  • Vacaturenummer 8460300
  • Locatie Breda
  • Contract Detachering via YER
  • Branche Medical & Health

Over deze vacature

Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this job opportunity.

Functie

  • Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations. Work together with production and maintenance team to resolve the quality related problems
  • Review and approve class I Non Conformances
  • Review and approve batch record exception reports
  • Coach production and maintenance staff to improve on quality and to limit number of errors
  • Perform finished product checks during (commercial) production runs
  • Complete batch release preparation prior to Qualified person disposition.

Bedrijf

At Amgen Breda, The Netherlands, we focus on the packaging and distribution part of the drugs we have developed which are produced at our international sites. The packaging and distribution is supported by the Operations, Customer Service and Demand, Information Systems and Quality departments.

Aanbod

You will be employed by YER and seconded to ASML. We offer:

  • Good employee benefits (e.g. work-life balance, pension, lease car, bonus model)
  • Challenging assignments
  • Excellent guidance from your consultant and YER's back office
  • Development opportunities, including the YER Talent Development Programme with a personal coach
  • Intensive support for international candidates (including Dutch lessons, tax-return and accommodation assistance)
  • Cooperative and results and relationship-driven
  • Friendly atmosphere and open culture
  • Community/network with other technology professionals from a variety of multinationals
  • Events and master classes with interesting speakers and attractive companies

Profiel

Minimum Requirements

  • EU Pharmacist degree (or equivalent) is required (e.g. BIG registered)
  • Preferably 0.5 year of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
  • Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
  • Manufacturing and/or Quality analytical processes and operations.
  • Fluent in English language.
  • Systems
  • TrackWise (NC/CAPA)
  • SAP
  • MS Office (Word, Excel)

Werum PAS-X (electronic batch Records)

Skills

  • Analytical
  • Work independent
  • Hands-on and result driven
  • Team player
  • Strong communication skills
  • Excellent in English
  • Quality mindset

Doorsturen