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Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Driving raw material qualification and release processes for scientific solutions, ensuring health authority compliance. Minimum 5 years laboratory experience in regulated environments and raw material qualification expertise required. Work in a highly regulated laboratory setting.
Anforderungen
- Degree in Chemistry, related discipline, or equivalent experience
- Minimum 5 years GMP laboratory experience
- Expertise in raw material qualification and release
- Knowledge of health authority expectations and compliance
- Proficiency in technical English
- Commitment to quality, compliance, and data integrity
- Structured, risk-based mindset and attention to detail
- Independent work and cross-functional collaboration skills
- Strong analytical thinking and problem-solving capabilities
- Excellent communication, organizational, and prioritization skills
- Interest in digitalization and QC process modernization
- Continuous learning mindset and motivation
Aufgaben
- Lead GMP-compliant raw material releases
- Drive QC-related material qualification processes
- Ensure alignment with health authority requirements
- Provide expert support for analytical deviations
- Manage OOS and OOT investigations
- Troubleshoot and drive continuous improvement initiatives
- Collaborate with internal and external laboratories
- Ensure robust analytical execution and data integrity
- Investigate deviations and manage change controls
- Author and maintain GMP-relevant documentation
- Conduct gap assessments and remediation measures
- Support health authority and customer inspections
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMP laboratory systems
- Analytical systems
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Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Driving raw material qualification and release processes for scientific solutions, ensuring health authority compliance. Minimum 5 years laboratory experience in regulated environments and raw material qualification expertise required. Work in a highly regulated laboratory setting.
Anforderungen
- Degree in Chemistry, related discipline, or equivalent experience
- Minimum 5 years GMP laboratory experience
- Expertise in raw material qualification and release
- Knowledge of health authority expectations and compliance
- Proficiency in technical English
- Commitment to quality, compliance, and data integrity
- Structured, risk-based mindset and attention to detail
- Independent work and cross-functional collaboration skills
- Strong analytical thinking and problem-solving capabilities
- Excellent communication, organizational, and prioritization skills
- Interest in digitalization and QC process modernization
- Continuous learning mindset and motivation
Aufgaben
- Lead GMP-compliant raw material releases
- Drive QC-related material qualification processes
- Ensure alignment with health authority requirements
- Provide expert support for analytical deviations
- Manage OOS and OOT investigations
- Troubleshoot and drive continuous improvement initiatives
- Collaborate with internal and external laboratories
- Ensure robust analytical execution and data integrity
- Investigate deviations and manage change controls
- Author and maintain GMP-relevant documentation
- Conduct gap assessments and remediation measures
- Support health authority and customer inspections
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMP laboratory systems
- Analytical systems
Über das Unternehmen
Thermo Fisher Scientific
Branche
Science
Beschreibung
The company enables customers to make the world healthier, cleaner, and safer through innovative scientific solutions.
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