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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:
Master's 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:
Strong interest in pharmaceutical production with willingness for long-term development in this field.Clear logical thinking and a rigorous scientific mindset.High initiative, strong learning ability, and enthusiasm.