Job Description:
- Conduct literature research for raw materials and finished products related to newly approved product development projects;
- Perform analytical method development, validation, and required testing activities, and prepare corresponding reports in compliance with applicable requirements;
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Conduct and report product, raw material, and packaging analyses according to current specifications and methods;
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Carry out stability analyses for new products, prepare and evaluate stability reports in line with regulations;
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Prepare analytical documentation sections of registration dossiers in CTD format for submission to the Ministry of Health;
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Prepare, update, and document standards (reference, working standards, etc.) used in analyses;
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Follow cGMP, U.S. FDA, PIC/S, ICH guidelines, and pharmacopoeias, ensuring they are continuously updated according to manufacturer information.
Qualifications: - Graduated from Chemistry or Chemical Engineering departments;
- Preferably holding or currently pursuing a master's degree in Analytical Chemistry or Pharmaceutical Chemistry;
- Minimum 2 years of analytical experience is required for the specialist role;
- Excellent command of English (both written and verbal);
- Strong teamwork and communication skills;
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Knowledge and hands-on experience in analytical method development, method validation, and stability studies;
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Experience in the use of HPLC, dissolution, GC and other analytical devices;
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Competent computer literacy, proficient in MS Office programs;
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Competent in planning and time management, teamwork aptitude, strong communication and relationship management skills;
- Ability to follow up-to-date scientific publications and regulatory guidelines in English;
- Analytical thinker with strong problem-solving orientation.
Conditions:
- Work schedule: 5/2 from 8:30 a.m. to 5:30 p.m;
- Lunches paid by the company.