Job responsibilities:
1. Assist the Department Manager and be responsible for the work results.
2. Make work summary and work plan for the next year before the end of December each year.
3. Independently prepare the first draft of DMF / cos, and further complete the revised draft after review.
4. Contact with the factory in DMF / cos draft preparation and revision, and answer customer's questions.
5. Follow up, supervise and inspect the sample testing experiments commissioned by other scientific research institutes.
6. Audit suppliers independently, and write audit reports in Chinese and English.
7. Check CoS / DMF documents prepared by department members and put forward modification suggestions.
8. Assist the Department Manager or cooperate with customers to carry out the quality work of pharmaceutical products, and assist customers and manufacturers to jointly solve the quality problems of trade products.
9. Organize, bind, register and register the internal documents and business files, and make quality records carefully.
10. Carry out professional training for subordinates and be responsible for their progress.
11. Finish other work assigned by superior.
Requirements:
1. Full time bachelor degree or above in pharmacy, chemistry, biochemistry and related major, master degree is preferred;
2. CET-6, fluent in listening, speaking, reading and writing, and can communicate in English as the working language;
3. At least two years working experience in GMP management of pharmaceutical factory; familiar with pharmaceutical raw material production, GMP in China and GMP required by international drug registration;
4. Familiar with ISO management system;
5. Familiar with international API registration process, cos, DMF document preparation;
6. Good communication skills, management skills, organizational skills, with a strong sense of responsibility.
fringe benefits:
Five insurances and one fund, double leave, paid annual leave, irregular employee activities, annual physical examination, welfare lunch, performance bonus, European training opportunities.
Promotion space:
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