CH12 Lonza AG
Senior QA Specialist, QA Project Management(m/w/x)
Vollzeitnur vor OrtSenior
Visp
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TEten23 health
Senior QMS & Compliance Expert(m/w/x)
Visp
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Planning and coordinating health authority inspections for pharmaceutical and biotech medicine development. 8-10 years in GMP-regulated pharma QA/Compliance, leading FDA/Swissmedic inspections required. Flexible working arrangements.
Anforderungen
- 8-10 years of experience in Quality Assurance and Compliance within a GMP-regulated pharmaceutical environment
- Experience leading and managing health authority inspections with FDA and Swissmedic inspectors
- Strong background in pharmaceutical GMP manufacturing, ideally sterile manufacturing
- Proven expertise in Quality Risk Management (QRM), including ownership and governance of risk registers
- In-depth knowledge of GMP regulations, guidelines, and industry best practices (e.g. EU GMP, FDA, ICH, Annex 1)
- Strong leadership, communication, and stakeholder management skills
- Structured, resilient, and confident in high-pressure regulatory situations
- Experience with customer audits as a CDMO is a plus
- Fluent in written and spoken English, German as a plus
Aufgaben
- Plan and coordinate health authority inspections
- Perform and track customer audits and self-inspections
- Act as the primary QA contact during inspections
- Prepare and manage CAPA plans with stakeholders
- Own and manage core quality processes
- Lead Quality Risk Management activities
- Conduct risk assessments and develop mitigation strategies
- Establish and maintain the risk register
- Document, review, and escalate risks appropriately
- Support continuous improvement of QMS processes
- Author, review, and approve SOPs and quality documentation
- Support follow-up activities for inspections
Berufserfahrung
- 8 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Flexibles Arbeiten
- Flexible working arrangements
Lockere Unternehmenskultur
- Open culture
- Diverse workforce
Weiterbildungsangebote
- Wide range of training options
Betriebliche Altersvorsorge
- Competitive pension fund plan
Boni & Prämien
- Annual bonus
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ten23 health 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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- Lonza
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Vollzeitnur vor OrtSeniorVisp
TEten23 health
Senior QMS & Compliance Expert(m/w/x)
Visp
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Planning and coordinating health authority inspections for pharmaceutical and biotech medicine development. 8-10 years in GMP-regulated pharma QA/Compliance, leading FDA/Swissmedic inspections required. Flexible working arrangements.
Anforderungen
- 8-10 years of experience in Quality Assurance and Compliance within a GMP-regulated pharmaceutical environment
- Experience leading and managing health authority inspections with FDA and Swissmedic inspectors
- Strong background in pharmaceutical GMP manufacturing, ideally sterile manufacturing
- Proven expertise in Quality Risk Management (QRM), including ownership and governance of risk registers
- In-depth knowledge of GMP regulations, guidelines, and industry best practices (e.g. EU GMP, FDA, ICH, Annex 1)
- Strong leadership, communication, and stakeholder management skills
- Structured, resilient, and confident in high-pressure regulatory situations
- Experience with customer audits as a CDMO is a plus
- Fluent in written and spoken English, German as a plus
Aufgaben
- Plan and coordinate health authority inspections
- Perform and track customer audits and self-inspections
- Act as the primary QA contact during inspections
- Prepare and manage CAPA plans with stakeholders
- Own and manage core quality processes
- Lead Quality Risk Management activities
- Conduct risk assessments and develop mitigation strategies
- Establish and maintain the risk register
- Document, review, and escalate risks appropriately
- Support continuous improvement of QMS processes
- Author, review, and approve SOPs and quality documentation
- Support follow-up activities for inspections
Berufserfahrung
- 8 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Flexibles Arbeiten
- Flexible working arrangements
Lockere Unternehmenskultur
- Open culture
- Diverse workforce
Weiterbildungsangebote
- Wide range of training options
Betriebliche Altersvorsorge
- Competitive pension fund plan
Boni & Prämien
- Annual bonus
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ten23 health 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
ten23 health
Branche
Pharmaceuticals
Beschreibung
The company is a human-centric strategic partner for the pharmaceutical industry and biotech start-ups, focusing on the development and testing of medicines.
Noch nicht perfekt?
- CH12 Lonza AG
Senior QA Specialist, QA Project Management(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist/QA Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist, DPS (Drug Product Services)(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Senior QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Vollzeitnur vor OrtSeniorVisp