Becton, Dickinson and Company
Assoc. Director, Quality Management, Contract Manufacturing(m/w/x)
Vollzeit
Senior
ab 200.000 / Jahr
Eysins
20
206030 Fresenius Kabi SwissBioSim GmbH1 Monat
(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Management
Vollzeit
Keine Angabe
1262 Eysins
Nejo KI-Zusammenfassung
In this role, you will ensure compliance with regulations for Medicinal Products while managing quality tasks and supporting GMP activities. Your day-to-day responsibilities will involve overseeing quality processes, conducting audits, and contributing to continuous improvement efforts.
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Anforderungen
- •BA/BS, MA/MS in scientific discipline or related field
- •5 years’ experience in Quality function in pharmaceutical industry
- •Strong understanding of GMPs, GDP, ICH guidelines
- •Significant experience as lead auditor for pharmaceutical manufacturing
- •Experience with regulatory agencies such as Swissmedic, EMA, FDA
- •Prior experience as deputy Responsible Person & interactions with Swissmedic
- •Fluency in English; German and/or French beneficial
- •Ability to work effectively in team-oriented environment
- •Leadership, Drive, Enthusiasm skills
- •Goal-Orientated and commitment to follow up on tasks
- •Decision Making, Problem Solving, Independence skills
- •Flexibility and willingness to travel (up to approx. 25%)
- •Proactive and Self-motivated
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
5 Jahre
Deine Aufgaben
- •Manage GDP-related quality tasks
- •Support GMP activities for trading Medicinal Products
- •Maintain knowledge of cGxP regulations and applicable standards
- •Implement requirements into local procedures
- •Act as deputy Responsible Person (RP)
- •Support GxP activities for commercial medicinal products
- •Contribute to maintenance of Quality Systems for Swissmedic licenses
- •Support due diligence and supplier qualification activities
- •Manage Quality Agreements and conduct audits
- •Oversee collection and processing of Events, Changes, and CAPAs
- •Notify management of events requiring immediate action
- •Develop and collect Key Quality/Compliance Indicators
- •Contribute to continuous improvement of quality processes
- •Identify training needs for the BU Pharma & Nutrition team
- •Contribute to internal audits and Health Authorities inspections
- •Support quality oversight of C(D)MOs and Testing Labs
- •Manage Quality Management Reviews for BU Pharma & Nutrition
Sprachen
Englisch – verhandlungssicher
Deutsch – Grundkenntnisse
Französisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 206030 Fresenius Kabi SwissBioSim GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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