Oversee sterile pharmaceutical manufacturing processes to ensure strict adherence to PICS/GMP and ISO 9001 standards
Supervise and coordinate sterile production staff to ensure all manufacturing activities align with the master production schedule
Coordinate with support departments such as Inventory and the engineering department to keep the workflow smooth and without delays
Analyze production deviations, assess process impacts, and implement comprehensive corrective and preventive action (CAPA)
Improved productivity by implementing Lean Manufacturing and OEE strategies, achieving a 66% OEE rating and reducing waste to 8%
Involved in the calibration, validation, and qualification of production machinery and equipment, e.g., mixing tank and piston filling machine
Apply the 6M Model to resolve immediate production issues and conduct root-cause investigations for deviations to prevent recurrence
Verify, Author and update pharmaceutical documents, including SOPs, BMR, WI and dossiers for drug e.g., WI for piston filling machine
Actively participate in Process Validation and Formulation Development in collaboration with the R&D department
Manage machinery maintenance and audit raw material/packaging inventory to ensure zero downtime and accurate stock levels
Provide technical guidance and performance evaluations for subordinates to maintain a highly skilled and safety-conscious team
Conduct training programs to ensure all personnel are proficient in sterile processing and safety protocols