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;

• Conduct and report product, raw material, and packaging analyses according to current specifications and methods;

• Carry out stability analyses for new products, prepare and evaluate stability reports in line with regulations;

• Prepare analytical documentation sections of registration dossiers in CTD format for submission to the Ministry of Health;

• Prepare, update, and document standards (reference, working standards, etc.) used in analyses;

• 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;

• Knowledge and hands-on experience in analytical method development, method validation, and stability studies;

• Experience in the use of HPLC, dissolution, GC and other analytical devices;

• Competent computer literacy, proficient in MS Office programs;

• 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.