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Functional head of quality control(m/w/x)
Quality control for cell-based ATMPs, including material/product checks and test procedure validation. Several years of GMP experience and §12 AMWHV compliance required. International teams, corporate sports, and health provision.
Requirements
- Completed science studies
- Several years of professional experience in quality control of cell-based ATMPs
- Extensive experience under GMP
- Worked as head of quality control in accordance with §12 AMWHV or fulfill requirements to complete training
- Ready to take on responsibility for ATMPs
- Strong understanding of analytical methods in quality control of cell-based ATMPs
- Experience with flow cytometry
- Experience with qPCR analyses
- Experience with endotoxin tests
- Experience with microbiological tests
- Structured, prudent, and solution-oriented manner
- High level of quality and responsibility
- Ability to motivate team to achieve top performance
- Willingness to work early, late, or evening if necessary
- Fluent English skills, spoken and written
- Desired German skills in speaking, reading, and writing
Tasks
- Ensure quality checks of materials and products
- Release or block products according to specifications
- Perform head of quality control duties
- Validate test procedures in operational teams
- Conduct and document necessary tests
- Qualify equipment and validate computer systems
- Participate in process improvement and efficiency
- Create GMP-relevant SOPs
- Maintain high quality standards
- Participate in self-inspections and audits
- Process open activities and anomalies
Work Experience
- approx. 4 - 6 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Fluent
- German – Basic
Tools & Technologies
- flow cytometry
- qPCR analyses
- endotoxin tests
- microbiological tests
Benefits
Informal Culture
- International teams
- Cross-border intercultural communication
- Room for creativity
Healthcare & Fitness
- Corporate sports activities
- Health provision
Learning & Development
- In-house Training Academy
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Functional head of quality control(m/w/x)
Quality control for cell-based ATMPs, including material/product checks and test procedure validation. Several years of GMP experience and §12 AMWHV compliance required. International teams, corporate sports, and health provision.
Requirements
- Completed science studies
- Several years of professional experience in quality control of cell-based ATMPs
- Extensive experience under GMP
- Worked as head of quality control in accordance with §12 AMWHV or fulfill requirements to complete training
- Ready to take on responsibility for ATMPs
- Strong understanding of analytical methods in quality control of cell-based ATMPs
- Experience with flow cytometry
- Experience with qPCR analyses
- Experience with endotoxin tests
- Experience with microbiological tests
- Structured, prudent, and solution-oriented manner
- High level of quality and responsibility
- Ability to motivate team to achieve top performance
- Willingness to work early, late, or evening if necessary
- Fluent English skills, spoken and written
- Desired German skills in speaking, reading, and writing
Tasks
- Ensure quality checks of materials and products
- Release or block products according to specifications
- Perform head of quality control duties
- Validate test procedures in operational teams
- Conduct and document necessary tests
- Qualify equipment and validate computer systems
- Participate in process improvement and efficiency
- Create GMP-relevant SOPs
- Maintain high quality standards
- Participate in self-inspections and audits
- Process open activities and anomalies
Work Experience
- approx. 4 - 6 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Fluent
- German – Basic
Tools & Technologies
- flow cytometry
- qPCR analyses
- endotoxin tests
- microbiological tests
Benefits
Informal Culture
- International teams
- Cross-border intercultural communication
- Room for creativity
Healthcare & Fitness
- Corporate sports activities
- Health provision
Learning & Development
- In-house Training Academy
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Miltenyi Biotec
Industry
Healthcare
Description
Das Unternehmen entwickelt einzigartige Lösungen für die biomedizinische Spitzenforschung sowie neuartige Zell- und Gentherapien.
Not a perfect match?
- Miltenyi Biotec
Funktionaler Leiter der Qualitätskontrolle(m/w/x)
Full-timeOn-siteSeniorBergisch Gladbach - Merck & Co., Inc., Rahway, NJ, USA
Quality Assurance Lead(m/w/x)
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Technical Assistant für die Qualitätskontrolle zellbasierter Therapien(m/w/x)
Full-timeOn-siteExperiencedBergisch Gladbach - Lonza Cologne GmbH
Quality Site Head(m/w/x)
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Leitung der Herstellung im Bereich Zell- und Gentherapie (CGT)(m/w/x)
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