1. Responsible for the drafting and review of new product changes, risk assessment and process documents;

2. Responsible for the experiment, amplification and data collation and summary of new processes;

3. Responsible for the statistical analysis of process parameters related to trial production and validation batches, timely report based on the analysis results, propose rationalization suggestions and implement them;

4. Responsible for the drafting, revision of process documents and related position standard operating procedures for subsequent process amplification and supervision of implementation;

5. Responsible for the summary and training sharing of trial production and process validation;

6. Responsible for the review of validation documents (including batch records, validation reports, cleaning records, etc.);