QC -

1.

2.HPLC

3.

4.OOS

5.

6.FDA / EMA

7.

USP

1.

2.

3.

Main Responsibilities

• Participate in technology transfer from R&D to production, review technology development reports and R&D quality documents, and draft technology transfer protocols.
• Perform testing and release of raw materials, excipients, intermediates, and finished products used in drug production; responsible for maintenance and calibration of analytical instruments such as HPLC.
• Draft and implement quality standard revisions, method optimization, and validation protocols.
• Investigate laboratory abnormalities, responsible for OOS, incidents, and deviations.
• Oversee laboratory compliance management and data integrity management.
• Participate in audit projects conducted by global health authorities such as FDA and EMA.
• Engage in operational excellence initiatives to improve laboratory efficiency.

Qualifications

Education :

Masters degree or above in Pharmaceutical Analysis or related fields; PhD preferred.

Experience :

Familiar with the United States Pharmacopeia (USP).

Language :

Fluent in English (listening, speaking, reading, writing).

Other Skills :

Proficient in using various analytical software systems.

Additional Competencies :