GMP Compliance Specialist (m/f/d)

Flexsis AG, IT-GITR

Flexsis AG, IT-GITR

Infos sur l'emploi

  • Date de publication :

    12 juillet 2024

  • Taux d'activité :

    100%

  • Type de contrat :

    Temporaire

  • Lieu de travail :

    4051 / Basel
INTRODUCTION
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.
ASSIGNMENT DESCRIPTION
  • 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
REQUIRED PROFILE
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:

Contact

  • Flexsis AG, IT-GITR

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