GMP Compliance Specialist

vor 1 Monat


Basel, Basel-Stadt, Schweiz CTC Vollzeit

Main Responsibilities:

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.
Qualifications and Experience:
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.
If you're interested in learning more about CTC and this exciting opportunity, please don't hesitate to get in touch with us. You can either use the 'apply now' button or reach out via email at . We look forward to hearing from you.

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