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

The company

Our client is a professional Pharmaceutical organization, based in Noord-Brabant Netherlands.

Role description

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.

Responsibilities

  • Review and approve class / 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

    The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent :

  • Bachelor's Degree in Life Sciences or related field or the equivalent combination of education and / or experience.
  • 3 Years 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

    Systems you have to work with :

  • TrackWise (NC / CAPA).
  • SAP.
  • MS Office (Word, Excel).
  • Werum PAS-X (electronic batch records).
  • Skills :
  • Analytical.
  • Analytical.
  • Works independent.
  • Hands-on and result driven.
  • Team player.
  • Strong communication skills.
  • Excellent in English
  • Quality mindset.
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