Senior Associate QA
SIRE
Noord-Brabant, The Netherlands
15 dagen geleden

The company

Our client is a professional organisation, based in Noord-Brabant Netherlands. Our customer is one of the largest supplier of medicines in the Netherlands.

This is a unique opportunity to work in one of the largest pharmaceutical companies in the world!

Role description

Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.

You will work together with production and maintenance team to resolve the quality related problems.

Responsibilities

  • 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.
  • 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.
  • Other information

    This job is 5 working days (mon-fri), in 3 shift operation - Early : 0630-1500 every other week - Late : 1430-2300 every other week -

    Night : 2230-0700 for now every 8 weeks (not first 3 months)

    Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.

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