Becton, Dickinson and Company
Assoc. Director, Quality Management, Contract Manufacturing(m/w/x)
Vollzeitnur vor OrtSenior
Eysins
ab CHF 158.600 - 253.775 / Jahr
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20206030 Fresenius Kabi SwissBioSim GmbH
(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Eysins
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Managing GDP quality tasks and GMP support for medicinal products, fulfilling deputy Responsible Person duties. Significant experience as lead auditor for pharmaceutical manufacturing required. Focus on critical quality assurance and regulatory compliance.
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
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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
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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20206030 Fresenius Kabi SwissBioSim GmbH
(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Eysins
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Managing GDP quality tasks and GMP support for medicinal products, fulfilling deputy Responsible Person duties. Significant experience as lead auditor for pharmaceutical manufacturing required. Focus on critical quality assurance and regulatory compliance.
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
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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
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.
Über das Unternehmen
206030 Fresenius Kabi SwissBioSim GmbH
Branche
Pharmaceuticals
Noch nicht perfekt?
- Becton, Dickinson and Company
Assoc. Director, Quality Management, Contract Manufacturing(m/w/x)
Vollzeitnur vor OrtSeniorEysinsab CHF 158.600 - 253.775 / Jahr - Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs CMC(m/w/x)
Vollzeitnur vor OrtSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Manager IV Fluids Global Portfolio(m/w/x)
Vollzeitnur vor OrtSeniorEysins - 206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Vollzeitnur vor OrtSeniorEysins - BD Biosciences
EMEA Senior Marketing Manager Life Science Research(m/w/x)
Vollzeitnur vor OrtSeniorEysinsab CHF 160.000 - 205.000 / Jahr