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Thermo Fisher Scientific
12d ago

Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)

Lengnau
Full-timeOn-siteSenior

Description

As a technical expert in raw material qualification, you will ensure GMP compliance and material integrity while leading complex quality topics to help the company's customers make the world healthier.

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Requirements

  • 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

Education

Bachelor's degree
OR
Master's degree

Work Experience

5 years

Tasks

  • 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

Tools & Technologies

GMP laboratory systemsAnalytical systems

Languages

EnglishBusiness Fluent

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