QA Technical Pharmacist

Responsibility: Responsible to review product specification and test method against the updated version of compendial pharmacopoeia and the registration file to ensure that the regulatory compliance is maintained. Initiate change control related to change in product specification and test method and coordinate with Quality team to support submission amendment, follow up, until implementation the new specification and test method. Coordinate with quality, production, product development and regulatory team to support stability study of the new project Primary review stability program for on-going stability study and special stability regarding to the change controls and stability of the new product / project. Follow up the stability data and also provide report / document to client in order to support new project requirement. Provide the registration dossier in part of stability for submission to health authority and also response to client and health authority for any query related to submission dossier. Support preparation of the Annual Product Quality Review (APR/PQR) within the established schedule in accordance with company and regulation requirements. Extraction and data compilation of analytical, manufacturing, quality control and regulatory data. Collect finished product and stability data for evaluation the product quality results and identify the product quality trend. Qualification: Bachelor’s Degree in Pharmaceutical Science. Experience in Pharmaceutical industry will be advantage. Good command in English and computer literacy. Strong interpersonal and communication skill, Hardworking, Pro-active, Analytical skill and problem-solving skill. Good technical writing skills, file organization and the ability to manage data is required. Strong understanding of relevant regulatory guidelines and requirements. High responsible with the timeline commitment. Patient, positive thinking and good attitude. Ability to manage multiple tasks.