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GMP Compliance Specialist

GMP Compliance Specialist

FLEXSISBasel, Basel, CH
Vor 3 Tagen
Stellenbeschreibung

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. 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 :