Dein persönlicher KI-Karriere-Agent
QA Expert, Manufacturing Release(m/w/x)
Batch release for aseptic drug products, including SOPs and change control. GMP compliance and deviation management experience required. Relocation assistance, agile career path.
Anforderungen
- BSc, MSc, or PhD in Natural Sciences or Pharmaceutical Sciences
- Experience in sterile drug product or substance manufacturing in GMP environment
- Experience in deviation and change management
- Work experience in QA is advantageous
- Hands-on personality, open approach to business partners, excellent influencing and negotiation skills
- Fluency in English
- German language skills are advantageous
Aufgaben
- Perform batch release for aseptic manufactured drug products
- Write, review, and approve procedures, SOPs, risk assessments, and gap assessments
- Ensure GMP compliance in electronic systems and paper-based documents
- Approve change requests, deviations, and CAPAs related to product and process
- Promote and enforce compliance with internal and external quality and safety guidelines
- Ensure required knowledge and skills, identify competency gaps, and develop solutions
- Lead development and evaluation of new tools, processes, and quality initiatives
- Be present at the manufacturing line to support manufacturing activities
- Support projects and maintain Sterile Production Stein line functions in GMP compliance
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Benefits
Sonstige Vorteile
- Relocation assistance
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic work culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Boni & Prämien
- Compensation programs for high performance
Mitarbeiterrabatte
- Lifestyle benefits
- Leisure benefits
Familienfreundlichkeit
- Family benefits
Gefällt dir diese Stelle?
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QA Expert, Manufacturing Release(m/w/x)
Batch release for aseptic drug products, including SOPs and change control. GMP compliance and deviation management experience required. Relocation assistance, agile career path.
Anforderungen
- BSc, MSc, or PhD in Natural Sciences or Pharmaceutical Sciences
- Experience in sterile drug product or substance manufacturing in GMP environment
- Experience in deviation and change management
- Work experience in QA is advantageous
- Hands-on personality, open approach to business partners, excellent influencing and negotiation skills
- Fluency in English
- German language skills are advantageous
Aufgaben
- Perform batch release for aseptic manufactured drug products
- Write, review, and approve procedures, SOPs, risk assessments, and gap assessments
- Ensure GMP compliance in electronic systems and paper-based documents
- Approve change requests, deviations, and CAPAs related to product and process
- Promote and enforce compliance with internal and external quality and safety guidelines
- Ensure required knowledge and skills, identify competency gaps, and develop solutions
- Lead development and evaluation of new tools, processes, and quality initiatives
- Be present at the manufacturing line to support manufacturing activities
- Support projects and maintain Sterile Production Stein line functions in GMP compliance
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Benefits
Sonstige Vorteile
- Relocation assistance
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic work culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Boni & Prämien
- Compensation programs for high performance
Mitarbeiterrabatte
- Lifestyle benefits
- Leisure benefits
Familienfreundlichkeit
- Family benefits
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Lonza
Branche
Pharmaceuticals
Beschreibung
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
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