北京招聘

岗位职责：
?Set up and manage the analytical services (chemistry) for the company’s manufacturing facilities in China.
?Create and maintain SOP’s systems to comply with US FDA and CFDA requirements.
?Manage the internal and external analytical development programs.
?Develop, validate and transfer analytical methods for the company in compliance with US FDA and CFDA regulations.
?Recruit and train staff to comply with US FDA and CFDA standards, reinforce training and motivate individuals.
?Train & develop subordinates.
?Other tasks assigned by superior.

任职资格的具体描述：
?Master Degree or above in Pharmaceutics, Analytical chemistry, Industrial pharmacy or similar, PhD is preferred;
?At least 10 years plus experience in analytical development of generic oral solid dosage forms within a US pharmaceutical manufacturing company;
?Working knowledge of US FDA and CFDA standards
?US ANDA and DMF requirements as related to lab methods operations and data handling and reporting
?Lab management
?Method development validation and transfer for US marketed of generic oral solid dosage forms
?Organization and operation of pharmaceutical testing laboratories including control and scheduling of workloads, budgets and employee training and development
?Leadership and Management skills
?Goal/task- oriented, strong sense of urgency organized and team leader.
?Strong communication skills in both written and verbal.
?Fluent English and Mandarin.

www.randstad.cn