NOR KAMILAH BINTI NORDIN

• Identify the constraints and improve the capacity of the manufacturing section by identifying the potential bottlenecks
• Apply appropriate Commissioning and Qualification strategy for assigned projects
• Support continuous process and quality improvements related deviations
• Make sure all production activities and area complies with EHS policies and procedures
• Standardize and improve process efficiency for upstream and downstream
• Design engineering support for manufacturing scale-up and implementation
• Work across organizational for gathering technical and quality inputs related to projects and production operations
• Ensure all documentation is accurate, timely, legible, complete and permanent (ALCOA principle)
• Review and follow up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements
• As department's training coordinator to make sure employees who involved in GMP activities undergo mandatory cGMP training, Microbiology, GDP, Data Integrity, GLP or any other GXP training, as applicable

Project Completed

• Commissioning of Purified Water Generator in DS facility‑Overcome the water capacity bottleneck and reduce the overall API manufacturing TAT by 24%
• Stand-alone equipment owner for new plant (Phase 2); vendor sourcing, budget planning, requirement finalization and installation planning including related validation.
• Existing production pipeline improvement; Pinhole issue

• Effectively guided technical project development and helped to steer and improve processes
• Planned and executed assigned engineering designs with accuracy
• Worked together with program managers to ensure proper and adequate technical staffing
• Executed design and development efforts in adherence to all engineering design standards
• Worked to quickly resolve technical conflicts and issues
• Developed and maintained project timelines
• Monitored and adjusted control systems
• Developed new process (ABS material plating) in production line (Inhouse production).

• Makes regular routine area inspection to ensure production equipment is in good condition
• Developed several improvements of production yield
• Eg: project entitled 'Mix Pairing Improvement'.