GMP Compliance Specialist
CTC Resourcing Solutions
- Basel
- Freiberuflich
- Vollzeit
- Management of local and global compliance processes such as GMP training, archiving, quality risk management, and handling of multisite and local impact assessments.
- Being an expert and providing 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 and building and growing relationships with customers and partners across functional boundaries.
- Must possess a relevant Swiss working/residency permit or Swiss/EU-Citizenship.
- Bachelor's or higher degree in chemistry, biology, or pharmaceutical sciences.
- Operational experience in a GMP environment within the pharmaceutical industry.
- Proficiency in MS Office/standard Google applications.
- Fluent in German, with 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.