• Location: Tuas
    Job Type : Contract
    Date: Friday, 04 January 2019
    Job Purpose 1) Serve as functional quality representative of external manufacturing in Asia Pacific region, including South Korea. Candidate will be required to liaise with colleagues and third party manufacturers in the APAC region, including South Korea. 2) Ensure that manufacturing operations are conducted and products are manufactured in accordance with GMP, the marketing authorization and the quality agreement. 3) Contribute to business operation by establishing partnership with third quality manufacturers and providing quality oversight and support for quality operations activities. Responsibilities Quality Management of third party manufacturers • Perform GMP audits of third party manufacturers and CAPA (Corrective action and preventive action) follow-up. • Complaints management. Review complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trend. • Management and support product recall and return. • Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend. • Deviation management and out-of-specification investigation. Review major / critical deviations, OOS investigations, CAPA plan and effectiveness review. Monitoring of deviations / OOS / CAPAs trends. • Participate in the evaluation, selection and approval of third party manufacturers • Management of Quality Agreement with third party manufacturers. Setup / review / update of quality agreement. • Management of Product Quality Reviews (PQR). Review of PQR, corrections/follow up action. Monitoring of PQRs trend. • Review of technical reports e.g. stability reports, process /analytical validation reports etc. • Quality Risk management in case of major / critical quality issue. Coordinate and participate quality risk meetings and prepare rapid quality notifications. • Management of Quality and Safety Material Product (QSMP). Setup / coordinate / review / update of QSMP. • Management of Quality Monitoring and Quality Review. Liaise with Korean-speaking counterparts to coordinate and participate in quality monitoring and quality review of third party manufacturers. • Perform risk ranking of third party manufacturers. • Manage termination of activity with third party manufacturers.