Quality Assurance Specialist

Job Description Summary Ensure the quality of the finished products that are imported and distributed by Country Organization is complied with both a) Korea Pharmaceutical Law and the related regulation and b) Novartis Corporate Quality Manual and Policies (Quality manual and the relevant SOP) including cGxP requirements Job Description Major Accountabilities Accountable for product compliance to local/international regulations as well as Novar tis Corporate Quality Policy. Ensure that all drug products are released to the market in a timely manner in accordance with the registered specifications and with local/international regulations. Manage the effective Change Control process. Manages the documentations and archiving of QA data and records to be compliant with local regulations, Novartis Corporate guideline and GMP requirements. Conducts the review of the accordance between the analytical testing specifications/methods and registered product license. Performs management of analytical method transfer and analytical testing documents transfer complied with both Novartis QM/QD and relevant SOPs under pharmaceutical law. Manage external inspections, complaints, deviations, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures and implement each CAPA timely. Manage technical complaints including reporting to appropriate investigation sites, managing investigation pr