岗位职责:
1. Execute separation campaigns, including batch separation and post-separation product dry
2. Fill up the production batch record timely and accurately in accordance with GMP/GLP guidelines
3. Perform instrument cleaning verification and maintain the proper operation of the separation suite, particularly the clean area
4. Perform inter-process purity check by analytical tools
5. Assist scientists to maintain the instruments in proper calibration and working order according to the appropriate SOP; help performing IQ/PQ/OQ calibrations as assigned
6. Assist scientists in tracking of the plant materials, e.g. raw materials, solvents, intermediates and final products etc
任职资格:
1. Must be trained in or be familiar with the requirements of the FDA cGMP/GLP regulations, ICH guidelines as well as drug development process.
2. Diploma in chemistry, pharmaceutical separation, biochemistry or other directly-related science discipline with experience or training in pharmaceutical analysis.
3. Must have experience with standard chromatography, both preparative and analytical techniques, particularly HPLC; experience/familiarity with separation chromatography instruments.
4. Strong communication skills, both written and verbal, and outstanding
interpersonal skills are essential job requirements.
5. Must be able to work in a team-oriented manner in order to accomplish performance objectives