350 Lilly Deutschland GmbH
Senior Manager Chemical Testing(m/w/x)
Vollzeitnur vor OrtSenior
Alzey
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35350 Lilly Deutschland GmbH
Principal Scientist - Quality Control Chemical Testing Lab(m/w/x)
Alzey
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
HPLC/UV-Vis and Empower system analysis for batch release of life-changing medicines. 5-10 years regulated industry experience in lab operations, with method validation per ICH guidelines and German/English skills, required. Excellent company pension plan.
Anforderungen
- Master’s degree or Bachelor in Analytical Chemistry, Chemistry, or Biology with extensive practical experience in GMP related field
- Minimum of 5-10 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements
- Hands-on experience in Chemical testing and relevant method validation/transfer per ICH guideline, including HPLC and UV-Vis
- Experience in working with Empower, LIMS and LES
- Written and oral skills in German and English
- Participation in Regulatory inspections as a SME such as EMA, FDA, etc.
Aufgaben
- Ensure timely completion of work to support batch release
- Adhere to EHS requirements and laboratory safety procedures
- Maintain cleanliness and contamination control per cGMPs
- Execute activities in compliance with SOPs and regulatory guidelines
- Record data according to data integrity standards
- Perform data review to ensure accuracy and compliance
- Identify and escalate atypical results and potential deviations
- Participate in root cause analysis for laboratory investigations
- Communicate opportunities for continuous improvement
- Participate in cross-functional teams as required
- Maintain training competencies and participate in mentorship
- Support audit and inspection readiness activities
- Perform comprehensive data reviews and prepare certification documents
- Participate in method transfers and validations
- Provide technical direction for the QC laboratory
- Lead resolution of complex QC technical challenges
- Collaborate across functions to integrate QC considerations
- Serve as a subject matter expert during regulatory inspections
- Mentor QC staff on advanced concepts and problem-solving techniques
- Sample incoming goods according to the sampling plan
- Handle samples to prevent contamination
- Label and document sample collection as per local procedures
- Transport samples to the designated area in a timely manner
- Communicate with Warehouse and QA to ensure proper sample collection
- Perform testing on incoming goods per established laboratory procedures
- Conduct routine checks and cleaning on equipment
- Report equipment malfunctions and coordinate maintenance
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- HPLC
- UV-Vis
- Empower
- LIMS
- LES
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Weiterbildungsangebote
- Access to professional development
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.
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35350 Lilly Deutschland GmbH
Principal Scientist - Quality Control Chemical Testing Lab(m/w/x)
Alzey
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
HPLC/UV-Vis and Empower system analysis for batch release of life-changing medicines. 5-10 years regulated industry experience in lab operations, with method validation per ICH guidelines and German/English skills, required. Excellent company pension plan.
Anforderungen
- Master’s degree or Bachelor in Analytical Chemistry, Chemistry, or Biology with extensive practical experience in GMP related field
- Minimum of 5-10 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements
- Hands-on experience in Chemical testing and relevant method validation/transfer per ICH guideline, including HPLC and UV-Vis
- Experience in working with Empower, LIMS and LES
- Written and oral skills in German and English
- Participation in Regulatory inspections as a SME such as EMA, FDA, etc.
Aufgaben
- Ensure timely completion of work to support batch release
- Adhere to EHS requirements and laboratory safety procedures
- Maintain cleanliness and contamination control per cGMPs
- Execute activities in compliance with SOPs and regulatory guidelines
- Record data according to data integrity standards
- Perform data review to ensure accuracy and compliance
- Identify and escalate atypical results and potential deviations
- Participate in root cause analysis for laboratory investigations
- Communicate opportunities for continuous improvement
- Participate in cross-functional teams as required
- Maintain training competencies and participate in mentorship
- Support audit and inspection readiness activities
- Perform comprehensive data reviews and prepare certification documents
- Participate in method transfers and validations
- Provide technical direction for the QC laboratory
- Lead resolution of complex QC technical challenges
- Collaborate across functions to integrate QC considerations
- Serve as a subject matter expert during regulatory inspections
- Mentor QC staff on advanced concepts and problem-solving techniques
- Sample incoming goods according to the sampling plan
- Handle samples to prevent contamination
- Label and document sample collection as per local procedures
- Transport samples to the designated area in a timely manner
- Communicate with Warehouse and QA to ensure proper sample collection
- Perform testing on incoming goods per established laboratory procedures
- Conduct routine checks and cleaning on equipment
- Report equipment malfunctions and coordinate maintenance
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- HPLC
- UV-Vis
- Empower
- LIMS
- LES
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Weiterbildungsangebote
- Access to professional development
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
Healthcare
Beschreibung
The company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those in need.
Noch nicht perfekt?
- 350 Lilly Deutschland GmbH
Senior Manager Chemical Testing(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Scientist - Quality Control Stability Program and Supply Chain(m/w/x)
Vollzeitnur vor OrtBerufserfahrenAlzey - 350 Lilly Deutschland GmbH
Expert Technician - Chemical Testing(m/w/x)
Vollzeitnur vor OrtJuniorAlzey - 350 Lilly Deutschland GmbH
Senior/Principal Scientist Validation(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Quality Control Expert Technician -- Incoming goods(m/w/x)
Vollzeitnur vor OrtJuniorAlzey