Plan, organize and oversee all activities related to the manufacturing of tablets and capsules to include delivery, in-process, and finished product samples in a defined schedule.
Review and compile the documents generated during the production of tablets and capsules such as batch manufacturing records and validation protocols.
Ensure and compliance with safety, quality, productivity, and performance expectations and execution of manufacturing operations.
Provide daily supervision and support to the operators in regarding day-to-day production activities such as trouble shooting and other work tasks.
Coordinate with departments such as Quality Assurance (QA), Quality Control (QC), Research & Development (R&D), Maintenance & Engineering, Supply Chain and Warehousing, Human Resources, and other internal functional partners with respective to the completion of quality work and achieving the production schedules and performance objectives.
Work with Integrated Product Development (IPD)/R&D on the execution of bio-batches (abbreviated new drug applications - ANDA) and validation batches.
Effective implementation of current good manufacturing practices (cGMP) and safety practices in the operations and manufacturing of products.
Initiate and review written procedures such as standard operating procedures (SOPs), operating instructions, cleaning procedures, safety procedures, and other work procedures as needed.