Chuyên Viên Độ Ổn Định R&D / R&D Stability Specialist

- Preparing the stability calendar for research samples and for pilot production samples
- Training other R&D personnel concerning Stability Topic
- Writing stability SOP’s
- Estimating the shelf-life of drug products with the use of statistical software
- Preparing stability reports
- Following SOP
- Managing stability samples: labeling stability samples, putting samples to stability chambers, withdrawal of samples at predefined stability points, and managing stability data.
- Writing stability part of the dossier
- Preparing protocols for stability testing

- Bachelor’s or higher degree of Pharmacy, Chemistry or similar
- Be able to write stability part of registration dossier
- Meticulous, honest.
- Be able to estimate shelf-life for drug products
- At least 3 years of relevant professional experience in stability management. Writing stability protocols and reports according to ICH requirements. Estimation of shelf life based on stability data of pilot productions. Preparation of stability calendar for pilot production samples and research samples.
- Prefer CV in English
- Have professional knowledge of ICH stability requirements for drug products
- Good command of English
- Be able to write stability protocols, reports, and conclusions
- MS Office: Microsoft Excel, Word
***Pickup bus from HCM to BD
Work location: Bình Dương province

Salary and bonus policies according to regulations of the company
Promotion opportunities
Work is stable and long-term

Cập nhật gần nhất lúc: 2022-05-25 13:32:03