QA Data Review Specialist

vor 4 Wochen


Basel, Basel-Stadt, Schweiz headcount AG Vollzeit

We are seeking a highly skilled QA Data Review Specialist to support our clients team in conducting data reviews for source documents and NDA Module submissions. This role requires prior QA experience in drug substance manufacturing, preferably in synthetic peptides.

Key Responsibilities:

  • Conduct reviews of process development and manufacturing raw data, as well as other data used for source documents and NDA Module submissions.
  • Ensure data review is in full compliance with regulatory standards and internal quality requirements.
  • Collaborate with cross-functional teams to address and resolve process-related queries.
  • Perform virtual electronic data reviews of CMO-generated data.

Key Requirements:

  • Strong background in drug substance (DS) manufacturing, process development, and process validation within a GMP environment (GMP production site)
  • Prior experience reviewing data for source documents and NDA Module submissions.
  • Fluency in French

As a QA Data Review Specialist at headcount AG, you will be part of a dynamic team that values expertise and collaboration. If you have a strong background in drug substance manufacturing and are fluent in French, we encourage you to apply for this exciting opportunity.



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