GMP Compliance Specialist

vor 1 Monat

Basel, Schweiz Flexsis Vollzeit

As a preferred supplier for Roche Basel, we are looking for a motivated

GMP Compliance Specialist (m/f/d)

This is a full/part-time position (80-100%) with a 1-year duration. The earliest start date is as soon as possible and the latest in June 2024. Home Office: 10% - max. 20% possible.

  • Management of local and global compliance processes like GMP training, archiving, quality risk management, handling of multisite and local impact assessments
  • Being an expert and first-level support for relevant quality systems (e.g. Cornerstone, Veeva OneQMS, QualityDocs, QRM)
  • Managing changes and deviations, as well as corrective and preventive actions in consultation with QA
  • Provide expert support to monitor, update, and adapt the GMP-relevant document landscape within pCMC
  • Participating in the preparation and coordination of internal and health authority audits, as well as supporting the timely implementation of inspection findings
  • Collaborating with team members in a role-based working environment, as well as building and growing relationships with customers and partners across functional boundaries

Must Haves:

  • Bachelor or equivalent and/or higher degree in chemistry, biology, or pharmaceutical sciences
  • Operational experience in a GMP environment within the pharmaceutical industry
  • MS Office / standard Google applications
  • Fluent in German, good verbal and written communication skills in English
  • Soft skills: detail-oriented and analytical mindset; ability to identify potential deficiencies, propose solutions, and effectively interpret and apply regulatory requirements; excellent communication skills; ability to collaborate efficiently with interdisciplinary teams in a dynamic environment.

Nice to Haves:

  • Experience in synthetic molecule manufacturing and/or quality control, as well as knowledge of GMP regulations (e.g., ICH Guidelines) and principles of quality systems is a plus.
Application process

Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise, we will be unable to process your application. Please upload your CV in English or German only, along with your degree certificate and the latest reference letter.

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