หน้าที่ความรับผิดชอบ

• Planning for the product formulation, manufacturing process and analytical method development for new pharmaceutical Oral solid dosage form according relevant regulatory guideline/ requirements.

• Evaluates and selects materials i.e. active pharmaceutical ingredient, excipient, other procession aid, and packaging material that is suitable for intended used in product and comply to regulatory requirements.

• Establishes the development study i.e. protocol and report of new product.

• Performing technology transfer of manufacturing process, formulation, analytical method, and relevant studies to commercial phase.

• Prepares and reviews the evaluation of the possibility of new product development , Dossier for drug registration, Dossier for drug registration.

• To ensure that all necessary qualification, maintenance, calibration, and validation of equipment, facility, and utility used in development process is carried out and the associated records evaluated.

• Work with all departments in implementing Investigating and complying with Quality Systems and GMP ISO13485, and ISO14000 requirements.