Mohd Norhafizan Mohd Rafani

With more than 6 years experiences and skills as an insulin production associate in manage and execute drug product aseptic filling operations.

BIOCON SDN BHD  Production drug-product Associates (NOV 2014- JUN 2021) Responsible for operating and troubleshooting production equipment in both aseptic and non-aseptic area • Experienced as a Filling Aseptic Operator. Always performed work in a safe and healthy manner and ensure that products are handled in a manner that does not affect quality and safety of costumers.  • Experience in handling and troubleshooting BOSCH COMBI filling machine, sealing machine, depyrogenation tunnel and vial washing machine. To provide and generate solution regarding any downtime to avoid any delay in production plan. • Experience in Autoclaving items to go to the filling suites (steam sterilization process). Responsible for preparing and autoclaving materials for filling (machine parts) according to their load pattern including planning and prioritization of those loads). • Experience in performing pre and post integrity testing for filters using in Insulin production (Novasip, SURF, Milipak 100). • Participated in Aseptic Process Simulation (APS) media fill. Performing various intervention required. Sound knowledge of continuous Good Manufacturing Practices (cGMP), ALCOA, ISO 9001, ISO 14001, Good Documentation Practice (GDPs) and Basic Microbiology. 

BACHELOR OF ENGINEERING (HONS) MANUFACTURING from INTERNATIONAL ISLAMIC UNIVERSITY MALAYSIA.