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Senior Expert QC(m/w/x)
Evaluating and selecting alternative microbiological methods for global validation and implementation. Pharmaceutical industry experience and leadership of international project teams required. Support dossier preparation and respond to health authority inquiries.
Requirements
- University degree in Microbiology or comparable scientific discipline
- At least 5 years of experience in microbiological QC laboratory
- Several years of practice within pharmaceutical industry
- Successful leadership of national and international project teams
- Experience in organizing QA workflows
- Excellent knowledge of microbiology
- Excellent knowledge of molecular biology
- Excellent knowledge of biotechnology
- Knowledge of relevant guidelines (GMP/GCLP/ISO)
- Very good command of English
- Confident interaction on global level
Tasks
- Evaluate and select alternative microbiological methods
- Coordinate global validation and implementation of methods
- Support dossier preparation as a Subject Matter Expert
- Respond to health authority inquiries
- Develop GMP-compliant validation strategies
- Provide scientific and technical support for investigations
- Provide scientific and technical support for deviations
- Establish global QC guidelines
- Represent company interests in international organizations
- Ensure knowledge transfer through technical reports
- Ensure knowledge transfer through publications
- Ensure knowledge transfer through benchmarking
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
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Senior Expert QC(m/w/x)
Evaluating and selecting alternative microbiological methods for global validation and implementation. Pharmaceutical industry experience and leadership of international project teams required. Support dossier preparation and respond to health authority inquiries.
Requirements
- University degree in Microbiology or comparable scientific discipline
- At least 5 years of experience in microbiological QC laboratory
- Several years of practice within pharmaceutical industry
- Successful leadership of national and international project teams
- Experience in organizing QA workflows
- Excellent knowledge of microbiology
- Excellent knowledge of molecular biology
- Excellent knowledge of biotechnology
- Knowledge of relevant guidelines (GMP/GCLP/ISO)
- Very good command of English
- Confident interaction on global level
Tasks
- Evaluate and select alternative microbiological methods
- Coordinate global validation and implementation of methods
- Support dossier preparation as a Subject Matter Expert
- Respond to health authority inquiries
- Develop GMP-compliant validation strategies
- Provide scientific and technical support for investigations
- Provide scientific and technical support for deviations
- Establish global QC guidelines
- Represent company interests in international organizations
- Ensure knowledge transfer through technical reports
- Ensure knowledge transfer through publications
- Ensure knowledge transfer through benchmarking
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
About the Company
Roche Diagnostics GmbH
Industry
Healthcare
Description
Das Unternehmen setzt sich dafür ein, Krankheiten zu verhindern, zu stoppen und zu heilen, und gewährleistet den Zugang zur Gesundheitsversorgung.
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