Compliance Scientist (m/w/d)
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Bern, Schweiz | 
Freelance
Zu besetzendes Projekt: Compliance Scientist (m/w/d)
Branche: BiotechFähigkeiten: Regulatory Affairs,compliance,biologic affairs
Projektstart: 26.08.2024
Projektdauer: 6 months
Einsatzort: Bern, Schweiz
Aufgaben:
Procedural documents management
- Support procedural document preparation/review and lifecycle management
- Ensure compliance of GRA with local and global procedural documents
- Maintenance of the company online glossary with GRA definitions
Training
- Training analysis and assignment
- Maintenance of training presentations
- Onboarding newcomers to the department
- Facilitate classroom training sessions
- Support annual reviews of training curricula
Compliance activities
- Support regulatory agency inspections and audits including pre-inspection and related follow-up activities as needed
- Audit readiness activities including managing eStaff Record filing repository
- Support tracking of audits & inspections performed in GRA
- Support management of quality non-compliance events in GRA, such as deviations and CAPAs
Qualifikationen:
- Bachelor degree in a Life Science or Business Advanced degree in a Life Science (PhD,MD) or Business (MBA) an advantage.
- 1+ years regulatory experience in the pharmaceutical industry. Biologics Regulatory experience preferred
Referenznummer: 15039
Branche: Biotech
Beginn des Projekts: 26.08.2024
Dauer: 6 months
Anstellungsart: Freelance
Kontakt
Luca Furler
