Establish analytical documents
- By establishing method of analysis based on Cfa analytical method and integrating with Ch.Ph requirement, and prepare related SOPs.
- Coordinate questions for laboratory methods and standards
Support to Regulatory on analytical issues.
- By handling analytical questions with Regulatory.。
- Compare SFDA issued specifications with Roche submitted dossier and evaluate the risk of the difference.
Coordinate between Regulatory and Technical (local and global) for technical registration requirement to meet product transfer and new product launch requirement.
- By collecting technical-related data and information issues requested by Regulatory.
- By managing and maintenance reference substances.
- Contact Cfa for analytical questions from QC.
Implementation of the optimization of MoA and Specification. Deliver project independently.
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