Die KI-Suchmaschine für Jobs
(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Beschreibung
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.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
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
Ausbildung
Berufserfahrung
5 Jahre
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
- Becton, Dickinson and CompanyVollzeitnur vor OrtSeniorab CHF 200.000 / JahrEysins
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(Senior) Manager – Quality operations and Deputy Responsible Person (RP)(m/w/x)
Die KI-Suchmaschine für Jobs
Beschreibung
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.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
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
Ausbildung
Berufserfahrung
5 Jahre
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
Über das Unternehmen
206030 Fresenius Kabi SwissBioSim GmbH
Branche
Pharmaceuticals
- Becton, Dickinson and Company
Assoc. Director, Quality Management, Contract Manufacturing(m/w/x)
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Vollzeitnur vor OrtSeniorEysins - SUSONITY
MSAT Process Expert Lead(m/w/x)
Vollzeitnur vor OrtSeniorAubonne - 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