We are looking for an Analytical Transfer and Validation Specialist for one of our prestigious client, within the QC Operations department of their northern Vaud site.
Responsibilities :
- Manage comprehensive validation studies to ensure the performance of analytical methods
- Write and review analytical transfer/validation/verification protocols, data, reports, test methods and other related documentation
- Analyze and interpret results of validation studies and prepare detailed reports
- Act as technical expert in analytical matters for several projects within the department
- Develop new analytical methods as part of the product development program.
- Manage the implementation of new raw materials by defining the required tests
Profil :
- Scientific background in biology, chemistry, biochemistry, chemical engineering, or a related field with 5 years of biotech industry experiences, in a GMP environment
- At least 4 years' experience in project management, analytical transfer and validation
- Perfect knowledge of ICH guidelines on analytical methods, stability, comparability and specification
- Fluent in French and English
Lieu de travail
1
2000 Neuchâtel
Contact
Morgane Cayuela
Write an email