Lilly
Senior Manager - Qualitätssicherung - Device Assembly and Packaging(m/w/x)
Vollzeitnur vor OrtSenior
Alzey
Neuer Job?Nejo!
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35350 Lilly Deutschland GmbH
Senior Quality Scientist, Device Assembly and Packaging(m/w/x)
Alzey
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Ensuring quality systems and GMP compliance for the final production of life-changing medicines, acting as process team contact. Five years pharmaceutical QA experience and German fluency required. Work in an advanced technology production facility.
Anforderungen
- Degree in science, engineering, pharmaceutical-related field or equivalent
- Five years pharmaceutical Quality Assurance experience
- Understanding of cGMP regulations and compliance
- Fluency in English and German
- On-site presence
- Experience in pharmaceutical manufacturing environments
- Experience with C&Q and Validation oversight
- Knowledge of US, EU, Japan regulations
- Proficiency with applicable computer systems
- Strong oral and written communication skills
- Interpersonal and teamwork skills
- Root cause analysis and troubleshooting skills
- Attention to detail and quality maintenance
- Ability to work independently or together
- Technical writing and communication skills
- Computer System Quality Assurance experience
- Experience with Manufacturing Execution Systems
- Use of KNEAT or electronic validation software
Aufgaben
- Maintain a safe work environment and lead safety initiatives
- Mentor and coach personnel on quality matters
- Monitor GMP programs and quality systems in operational areas
- Act as the Quality point of contact for the process team
- Assess and triage deviations within the local process team
- Resolve product issues with support groups and external partners
- Support regulatory inspections and participate in self-led audits
- Review and approve quality documents and technical studies
- Participate in continuous improvement projects to boost productivity
- Approve validation documents for computer systems and equipment
- Benchmark best practices with Global Parenteral Network sites
- Provide guidance on non-conformance investigations and change controls
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- C&Q
- Validation oversight
- Computer systems validation
- Manufacturing Execution Systems
- KNEAT
- Electronic validation software
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Advanced technology production facility
Lockere Unternehmenskultur
- Creative freedom
Karriere- und Weiterentwicklung
- Individual career development
Weiterbildungsangebote
- Professional development worldwide
Ergonomischer Arbeitsplatz
- Workplace accommodation
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 350 Lilly Deutschland 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.
Noch nicht perfekt?
- 350 Lilly Deutschland GmbH
Scientist – TSMS Device Assembly and Packaging(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Senior Quality Associate, Parenteral(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Senior/Principal Scientist Validation(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Technician - Quality Assurance - Device Assembly and Packaging(m/w/x)
Vollzeitnur vor OrtBerufserfahrenAlzey
35350 Lilly Deutschland GmbH
Senior Quality Scientist, Device Assembly and Packaging(m/w/x)
Alzey
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Ensuring quality systems and GMP compliance for the final production of life-changing medicines, acting as process team contact. Five years pharmaceutical QA experience and German fluency required. Work in an advanced technology production facility.
Anforderungen
- Degree in science, engineering, pharmaceutical-related field or equivalent
- Five years pharmaceutical Quality Assurance experience
- Understanding of cGMP regulations and compliance
- Fluency in English and German
- On-site presence
- Experience in pharmaceutical manufacturing environments
- Experience with C&Q and Validation oversight
- Knowledge of US, EU, Japan regulations
- Proficiency with applicable computer systems
- Strong oral and written communication skills
- Interpersonal and teamwork skills
- Root cause analysis and troubleshooting skills
- Attention to detail and quality maintenance
- Ability to work independently or together
- Technical writing and communication skills
- Computer System Quality Assurance experience
- Experience with Manufacturing Execution Systems
- Use of KNEAT or electronic validation software
Aufgaben
- Maintain a safe work environment and lead safety initiatives
- Mentor and coach personnel on quality matters
- Monitor GMP programs and quality systems in operational areas
- Act as the Quality point of contact for the process team
- Assess and triage deviations within the local process team
- Resolve product issues with support groups and external partners
- Support regulatory inspections and participate in self-led audits
- Review and approve quality documents and technical studies
- Participate in continuous improvement projects to boost productivity
- Approve validation documents for computer systems and equipment
- Benchmark best practices with Global Parenteral Network sites
- Provide guidance on non-conformance investigations and change controls
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- C&Q
- Validation oversight
- Computer systems validation
- Manufacturing Execution Systems
- KNEAT
- Electronic validation software
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Advanced technology production facility
Lockere Unternehmenskultur
- Creative freedom
Karriere- und Weiterentwicklung
- Individual career development
Weiterbildungsangebote
- Professional development worldwide
Ergonomischer Arbeitsplatz
- Workplace accommodation
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 350 Lilly Deutschland 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
350 Lilly Deutschland GmbH
Branche
Pharmaceuticals
Beschreibung
The company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those in need.
Noch nicht perfekt?
- Lilly
Senior Manager - Qualitätssicherung - Device Assembly and Packaging(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Scientist – TSMS Device Assembly and Packaging(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Senior Quality Associate, Parenteral(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Senior/Principal Scientist Validation(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Technician - Quality Assurance - Device Assembly and Packaging(m/w/x)
Vollzeitnur vor OrtBerufserfahrenAlzey