The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work
Job Summary
The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work.
The Site RP (Responsible Person) is a key member of the Quality Leadership Team, having responsibility to ensure that the site meets the expectations as laid out in the Swissmedic Technical Interpretation (I-SMI.TI.17).
Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
Matching Summary
The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work.
Skills & Requirements
Must-have
Biologics drug substance manufacturing
Clinical supply packaging and distribution
Swissmedic Technical Interpretation (I-SMI.TI.17)
Batch release and certification
Deviation and OOS investigations
Internal audit program oversight
Health Authority notifications
Nice-to-have
Cross-functional teamwork and collaboration
Influencing and negotiation skills
Continuous improvement initiatives
Permanent inspection readiness
Key Requirements
Bachelor’s degree, or higher, in a Life Science discipline
10 Years + Experience in Quality Role
Eligible as Responsible Person as per I-SMI.TI.17
Previously acted as a Responsible Person
Strong Experience in Quality Related enterprise systems
Experience in supporting regulatory inspections, specifically, Swissmedic