GMP Compliance Specialist
vor 2 Wochen
Start date: Immediately, latest 1st June
Duration: 1 year
Responsibilities:
- 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
Requirements:
- 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 and English
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