Quality & Compliance Specialist (Italy) (f/m/d) - Wien
Nur für registrierte Mitglieder Wien, Österreich
vor 1 Monat
* Diese Gehaltsspanne ist eine Schätzung von beBee
Job summary
In this role, you will ensure compliance with regulatory and corporate requirements while supporting our local Quality Management System.
Responsibilities
- Support the Quality Management System (QMS/eQMS) in compliance with GxP and corporate procedures.
- Draft, update, and maintain quality documentation and SOPs.
- Provide training (onboarding and recurring) on quality and compliance processes.
- Manage incidents, complaints, CAPAs, deviations, and returns.
- Ensure compliance in daily operations, including documentation and archiving (paper and digital).
- Conduct supplier and customer qualification.
- Coordinate internal and external audits, including follow-up and CAPA plans.
- Monitor compliance with GDP, GVP, GDocP, Legislative Decree 219/2006, AIFA, EMA, and other regulations.
- Support corporate compliance policies (anti-bribery, transparency, HCP interactions, scientific information, drug traceability).
- Handle transparency reporting (Sunshine Act) and approval workflows for promotional materials, events, donations, and sponsorships
Stellenbeschreibung
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