Section Leader

Job Outline: 1. To supervise a team of Process Assistant / Technologist / Line Leader within the respective section. 2. To be responsible in delivering production output in accordance with the production schedules. 3. To execute all means necessary to ensure the manufacturing equipment and process areas within the respective section of charge in compliance with cGMP and quality standards. 4. To assist in implementation of systems and procedures to improve efficiency and effectiveness of manufacturing processes and products quality. Duties and Responsibilities: 1. To meet the pre-planned production schedules, productivity targets such as cycle time, wastage, yields, quality objectives and agreed supply plan for all the production lines related to his/her area of charge. 2. To ensure adequate resources are allocated according to the plan in order to ensure smooth functions of quality control and production system. 3. To approve or buyoff the process during initial setup before commencing the production and control the product quality within specification throughout the batch manufacturing process. 4. Take accountability to ensure pharmaceutical products are manufactured according to quality standards and product specifications. 5. To stop production and inform superior if detect any abnormity and deviation that can cause impact to the identity, quality, purity and efficacy of product. 6. To oversight and assist in set-up, batches conversion, cleaning and problem rectification on machinery and supporting system in production floors. 7. To operate and be accountable to operation of various production equipment under controlled conditions as per standard operating procedures. 8. To collaborate with maintenance technicians in preventive maintenance and calibration program according to the planned schedule and daily checks to support the manufacturing operation. 9. To lead Process Assistant / Technologist / Line Leader for equipment trouble shooting activities and issue work requests for maintenance when applicable. 10. Responsible to maintain cGMP and quality standards for the manufacturing equipment and process areas within the respective or related area of charge. 11. To ensure all the production and quality and manufacturing records / documents are updated accordingly. 12. To actively participate in investigation of all major and / or minor failures or nonconformity of semi products or finished goods and ensure agreed actions are implemented to prevent their recurrence, etc. 13. To ensure Process Assistant / Technologist / Line Leader is well trained on the correct operational and cleaning methodology of machineries / premises, material requisition, area clearance, reconciliation procedures, in process sampling checking and testing, environmental monitoring, cGMP, etc. in line with Standard Operating Procedures and Batch Manufacturing Records. 14. To resolve or escalate any issue highlighted by subordinate related to material requisition to management. 15. To implement and practice good housekeeping and 5S in the respective section. 16. Ensure all job activities are performed in a safe manner and shop floor staffs are adhering to all safety procedures. 17. To work closely with Production Unit Manager / Executive / Pharmacist and participate in departmental improvement projects. 18. To ensure shop floor staffs are adhering to all safety procedures. 19. To review job sheet and check for WIP reconciliation. 20. To ensure all log books are updated and pass to Production Executive/ Production Pharmacist/ Production Unit Manager to review and check on every month end. 21. To actively participate in process failure or product nonconformity's root causes investigation and correction / prevention action implementation. 22. To perform any other jobs as assigned to you by your superior from time to time.
Founded in 1967 in Singapore, Xepa has grown and evolved at the cutting edge of the industry. From our modest first years when Xepa Laboratories Pte. Ltd. produced a limited range of pharmaceutical products in a small flatted factory, we have relocated twice to larger manufacturing plants in Melaka, Malaysia. Today, Xepa is the leading manufacturer of off-patent pharmaceuticals in Malaysia.
STPM / A Level or Equivalent