Aktuelle Jobs im Zusammenhang mit GMP Compliance Specialist - Basel - Flexsis
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Basel, Basel-Stadt, Schweiz Roche Vollzeit**About Us:** Roche is a global leader in pharmaceuticals and diagnostics. In the field of synthetic molecules, we are committed to delivering innovative solutions that improve human health.As a key member of our GMP Support & Compliance team, you will play a crucial role in ensuring compliance with regulatory requirements. You will be working in close...
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Compliance Specialist
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Basel, Basel-Stadt, Schweiz Roche VollzeitKey ResponsibilitiesDelegate of the Swiss RP for IMPs: Act as a representative of the Swiss regulatory authority for Investigational Medicinal Products.GMP Compliance: Ensure adherence to Good Manufacturing Practice guidelines across all stages of IMP production, from manufacture to release.Procedure Review and Approval: Review and approve GMP procedures,...
GMP Compliance Specialist
vor 1 Monat
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.
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.
- 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.
