QC Development Senior Engineer

Job requirements:

1. Bachelor degree or above in analytical chemistry or related majors, CET-6, with more than 3 years of analytical work experience;

2. Proficient in analytical instruments such as HPLC, LC-MS, GC, GC-MS, NMR, as well as the principles and applications of microbial detection; Familiar with GMP, ICH, and relevant testing regulations, familiar with USP/EP/CP testing requirements;

3. Master the use and maintenance of a micro preparation system that shares the same principle as the analytical instrument system;

4. Ability to independently diagnose and troubleshoot analytical instrument faults (except for hardware faults);

5. Have good English reading and writing skills, as well as certain external communication skills;

6. Having the ability to independently analyze the causes of OOS and deviations, propose solutions, and prevent the recurrence of similar problems.

Job Description:

1. Responsible for searching for analytical methods for new products (including raw materials) and establishing testing methods and standards;

2. Optimize methods and develop and validate new testing methods in accordance with GMP, ICH, and relevant testing regulations;

3. Responsible for identifying unknown impurities and deriving their possible structures;

4. Responsible for guiding the grassroots department to confirm the structure of new products and solve technical problems;

5. Responsible for introducing and establishing new analytical methods related to the company, designing SOPs, and verifying them;

6. Responsible for reporting project progress in English, answering customer questions about testing data in writing, and communicating with customers;

7. Complete other tasks assigned by the company and department.