Process Line Leader
5 days ago
Job Outline: 1. To supervise a team of Process Assistant / Technologist within the respective section. 2. To be responsible in delivering production output in accordance with the production schedules. 3. To assist in ensuring 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 and quality objectives for all the production lines related to his/her area of charge. 2. To optimize resources that are allocated 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 ensure in process quality control checks and tests are carried out in a timely manner. 6. To ensure environmental monitoring is carried out according to the predetermined schedule and Standard Operating Procedures. 7. Stop production and inform superior if detect any abnormity and deviation that can cause impact to the identity, quality, purity and efficacy of product. 8. Responsible to maintain cGMP and quality standards for the manufacturing equipment and process areas within the respective or related area of charge. 9. To ensure all the production and quality and manufacturing records / documents are updated accordingly. 10. To ensure material requisition is performed and received prior to starting of batch process and to highlight to superior if issue arises. 11. To ensure Process Assistant / Technologist 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. 12. To implement and practice good housekeeping and 5S in the respective line. 13. To ensure shop floor staffs are adhering to all safety procedures. 14. To work closely with Production Unit Manager / Executive / Pharmacist / Process Section Leader and participate in departmental improvement projects. 15. To ensure daily Productivity Index is updated accurately. 16. To review job sheet and check for material reconciliation. 17. To ensure all log books are update and pass to Production Executive / Production Pharmacist / Production Unit Manager review on every month end. 18. 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.
SPM / O Level / SKM Level 1 / SKM Level 2 / SKM Level 3 or Equivalent
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