Senior Biotechnology QA Associate
SIRE
,
11 dagen geleden

The company

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

Brabant Netherlands which has +100 people working on the site. They have a large portfolio of medicines from investigational medicinal products to finished dosages.

Role description

The Quality Assurance Associate makes sure that the quality is within the product and that the product meets the industry and safety regulations.

You will always collaborate with everyone on site and together you make sure there are no impurities and all specifications are met.

Responsibilities

  • 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

  • Coach production and maintenance staff to improve on quality and to limit number of errors
  • Review and approve class I Non Conformances
  • Review and approve batch records
  • Complete batch release preparation prior to Qualified person disposition
  • Perform finished product checks during production runs
  • Requirements

  • MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and / or experience.
  • Typically 3 (Bachelor) or 5 (MBO) 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.
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