206030 Fresenius Kabi SwissBioSim GmbH
(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Vollzeit
Keine Angabe
Eysins
HA
Haleon3 Tage
QA Suppliers Oversight Specialist(m/w/x)
Vollzeit
Senior
Keine Angabe
1260 Nyon
Nejo KI-Zusammenfassung
In this role, you will be the vital link between the Nyon plant and its suppliers, managing quality assurance activities, handling complaints, and ensuring compliance with regulatory standards. Your day-to-day responsibilities will include overseeing documentation, participating in audits, and supporting supplier qualifications.
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Anforderungen
- •Minimum of 5 years industry experience
- •Minimum of 2 years full-time supplier related activities
- •Use of risk management tool and standard quality tool
- •Working knowledge of regulatory agency requirements
- •Experience in international & multidisciplinary environments
- •Willingness to travel worldwide
- •University degree in Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
- •High knowledge of GMP regulations and requirements on supplier management
- •Good knowledge on raw materials / packaging material production processes
Bachelor-Abschluss
Berufserfahrung
5 Jahre
Deine Aufgaben
- •Act as the key quality interface between the Nyon plant and suppliers
- •Manage documentation for QA supplier activities
- •Handle audit requests and escalate issues to Global Supplier Quality Operations
- •Address quality-related complaints for suppliers and third-party service providers
- •Support the qualification process for suppliers and service providers
- •Contribute to the self-inspection program
- •Participate in external inspections and audits
- •Maintain Quality Agreements and ensure PRS/SRS are up-to-date
- •Handle Quality Incident Reports (QIRs) and keep the approved suppliers list current
- •Perform Quality Risk Analyses for suppliers and service providers
- •Oversee supplier-related changes and notifications
- •Follow up on complaints regarding raw materials and packaging
- •Draft and review Standard Operating Procedures for QA supplier activities
- •Ensure accurate completion of QA supplier oversight records
- •Support external inspections and audits on site
- •Ensure compliance with GMP and HSE requirements
Tools & Technologien
Fishbone5WhyFMEA
Sprachen
Englisch – verhandlungssicher
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