1. Lead a supportive team, which covers document management, equipment/instrument management, equipment calibrations and maintenance, facility cleaning, and supporting CT manufacturing.
2. Organize, instruct and supervise the IQ/OQ/PQ activities for new equipments and GMP facilities.
3. Cooperate with QA department regarding to equipment and facility qualification and product quality related issues. Initiate SOP writing and revision.
4. Coordinate with Engineering Department for equipment installation, GMP facility modification and expansion.
职位要求：
1. MS or h.D. degree in Pharmaceutics or other directly related science discipline with experience or training in formulation development and manufacturing
2. Must be proficient with the requirements of the s-FDA/US-FDA/ EMEA cGMP regulations, ICH guidelines as well as drug development process.
3. Prior experience in working in GMP environment. Must be able to work in a team-oriented manner in order to accomplish performance objectives.
发表于 2013-1-6 16:39:57
h.D. degree in Pharmaceutics or other directly related science discipline with experience or training in formulation development and manufacturing