Overview
In Grünenthal’s Manufacturing & Global Operations, you help safeguard product quality across the value chain by leading change controls, PQR issuance, CAPA-driven improvements, and master data validation. You collaborate with cross-functional teams to ensure regulatory compliance and licensing obligations are met while driving continuous quality improvements. This role offers hands-on QA responsibilities with meaningful impact on patient safety and product excellence.
Retribuzione / Benefits
- performance-based annual bonus
- equal employment opportunities
Responsabilità
- Manage change controls across sites
- Plan and execute site trainings
- Issue and revise Product Quality Reviews (PQR)
- Participate in self-inspections and CAPA management
- Revise Master Batch Records
- Issue validation protocols and reports
- Participate in risk assessment management
- Cooperate in revising qualification and validation documentation
- Oversee Quality Agreement with customers
- Support regulatory activities to maintain manufacturing licenses
- Collect and monitor site KPIs
Requisiti fondamentali
- Degree in Scientific disciplines
- 3–5 years of experience in Quality Assurance within pharmaceutical sector
- Knowledge of local and international regulatory requirements and GMP standards
- Competency in communication and interfaces management
- Fluent English
- communication
- stakeholder management
- team collaboration
- GMP knowledge
- regulatory compliance
- CAPA
Senior QA Systems Specialist datore di lavoro: Grunenthal
L'azienda offre un ambiente di lavoro stimolante e collaborativo, dove i dipendenti possono crescere professionalmente attraverso opportunità di sviluppo continuo e formazione. Con un forte focus sulla sicurezza e il rispetto delle normative GMP, il ruolo di Maintenance Planner & Reliability Engineer consente di contribuire a pratiche di manutenzione all'avanguardia in un contesto di produzione globale. Inoltre, l'azienda promuove una cultura inclusiva e offre un bonus annuale basato sulle performance, rendendola un datore di lavoro eccellente per chi cerca un impiego significativo e gratificante.