\xe2\x80\xa2 Supervise all manufacturing personnel and activities to ensure the successful time sensitive GMP manufacture and release of products minimal to zero deviations \xe2\x80\xa2 Provides day-to-day oversight of the cleaning crews; including scheduling activities, overseeing training and providing input regarding personnel changes \xe2\x80\xa2 Develop and drive execution of a daily schedule \xe2\x80\xa2 Performs and monitors day to day manufacturing operation activities; ensures and verifies compliant execution with cGMP standards and procedures from the cGMP manufacturing areas. \xe2\x80\xa2 Operates pharmaceutical manufacturing equipment such as: Formulation system, Vial washing, sterilisation and depyrogenation, and filling, stoppering and crimping. \xe2\x80\xa2 Demonstrates, understands and adheres to Company\xe2\x80\x99s policies, GMP standards and safety procedures \xe2\x80\xa2 Troubleshoot, advanced maintenance and repair activities on equipment and systems used in Manufacturing according to Standard Operating Procedures (SOPs) \xe2\x80\xa2 Perform and monitor critical processes, execute routine validation protocols, work orders \xe2\x80\xa2 Informs manager on progress of projects, transfer of data, process details, etc. \xe2\x80\xa2 Executes batch records according to GMP and site quality standards \xe2\x80\xa2 Generates Batch Records, SOPs and Protocols as required \xe2\x80\xa2 Responds to off-hour alarms as assigned by manager \xe2\x80\xa2 Executes manufacturing cleanroom changeover and activation \xe2\x80\xa2 Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment \xe2\x80\xa2 Supports QA during audits and regulatory inspections \xe2\x80\xa2 Supports other manufacturing process teams, QC Team and other groups as necessary to achieve Manufacturing team goals
SGB has incorporated a new wholly-owned subsidiary, Solution Biologics Sdn. Bhd., to undertake the supply of vaccines and biologics. For the initial phase of the business, Solution Biologics Sdn. Bhd will operates a fill and finish facility dedicated to vaccines and biologics. The facility will be housed in the current manufacturing building at Technology Park Malaysia and expected to be operational by first quarter of 2021. Biologics and vaccines represent one of the fastest growing classes of therapeutic molecules in modern healthcare. The annual global biologics market is expected to be approximately USD 380 billion by 2024, representing a relatively higher growth rate (~8%) compared to conventional pharmaceuticals. Currently, more than 350 biologics are commercially presented in the biopharmaceuticals market. Since biologics are quite large in comparison to chemical-based drugs and made up of proteins, they require extra care to maintain their size, shape, form, and stability. These factors correlate to the intended effect and efficiency of the biologic drug. We are committed to developing newer and more effective vaccines and biologics through research and development programme with our partners. Our plan for the future will include paediatric and adult vaccines that are part of the National Immunisation Schedule of Malaysia and the Extended Programme of Immunisation (EPI) of various countries in the region.
Bachelor\'s or Equivalent