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Mô Tả Công Việc
- To ensure that the functioning of the laboratory adheres to GLP/GMP requirements.
- To spearhead the team in Analytical method development, analytical testing and troubleshooting.
- To keep abreast of all technological developments, and work in collaboration with the Formulation Development department towards the implementation of these new technologies.
- To help liaison with external CROs to carry out analytical activities externally.
- To facilitate cross functional activities to ensure project deliverables
- To approve/reject raw materials, in process and finished products, laboratory protocols, reports, specification, and review deviations etc.
- To manage and plan the internal or external Analytical Studies to ensure the follow-up of studies within the required time limits and according to allocated budgets
- To manage the API qualification and Review drug master files (if any) with HQ
- To review of technical documents meant for regulatory submissions
- To provide required technical document and analytical support to RA to facilitate and achieve targets of regulatory submissions
- To manage the personnel and organization of Analytical laboratory, ensuring the achievement of qualitative and quantitative goals of the laboratory through the performance of team
- To manage the budget of R&D Analytical laboratory.
Yêu Cầu Công Việc
- Minimum of 3 years’ experience in the similar positions at multinational companies
- Good knowledge/experience of analytical technique, instrumentation and qualification procedures in pharmaceuticals ingredients/ products qualification and quantification methods
- Strong experience of working in a cGMP/GLP environment. Having knowledge of ICH guidelines and pharmacopoeia requirements
- General knowledge of the pharmaceutical drug development process.
- Strong experience of method development, method validation and method transfer requirements.
- Good understanding of statistical tools in applied analytical chemistry
- Proven leadership skill and strong personal skills
- Good at English & IT skills (data processing software…)
- Ability to work under pressure, teamwork, determined.
- Working place: Song May IZ, Trang Bom, Dongnai.
We will contact the suitable candidates.