Senior Scientist, Material Qualification & Release (QC GMP)Thermo Fisher Scientific • Lengnau, Switzerland
Senior Scientist, Material Qualification & Release (QC GMP)
Thermo Fisher Scientific • Lengnau, Switzerland
Vor einem Tag
StellenbeschreibungAct as investigator for deviations and assigned change controls, ensuring timely and compliant resolution. Author, review, and maintain GMP-relevant documentation (SOPs, risk assessments, reports, protocols). Conduct gap assessments and define / implement remediation measures to maintain inspection readiness. Support and actively participate in health authority and customer inspections and audits. Bachelor’s or Master’s degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or a related scientific discipline. Equivalent professional experience in a GMP-regulated pharmaceutical or biopharmaceutical environment will be considered. Minimum 5 years of experience in a GMP laboratory within the pharmaceutical or biopharmaceutical industry. Demonstrated expertise in raw material qualification and release within a GMP-regulated manufacturing environment. Strong working knowledge of health authority expectations and regulatory compliance. Proficiency in technical English (written and spoken). Strong commitment to quality, compliance, and data integrity. Structured, risk-based mindset with high attention to detail. Ability to work independently while effectively collaborating cross-functionally. Strong analytical thinking and problem-solving capabilities. Excellent communication, organizational, and prioritization skills. Interest in digitalization and modernization of analytical systems and QC processes. Continuous learning mindset with motivation to further develop technical and regulatory expertise.
Material Qualification & Release
- Lead and execute the GMP-compliant release of raw materials used in manufacturing.
- Drive the QC-related aspects of material qualification to ensure full alignment with health authority and regulatory requirements.
- Serve as SME for raw material analytics, providing expert support during deviations, OOS / OOT investigations, troubleshooting, and continuous improvement initiatives.
- Collaborate with internal and external laboratories to ensure robust analytical execution and data integrity.
Compliance & Regulatory Readiness
Who We Are Looking For
Education
Experience
Skills & Competencies
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Senior Scientist Material Qualification Release QC GMP • Lengnau, Switzerland
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