This role is responsible for the cGMP aspects of the entire manufacturing operation. Administering the MBR (Master Batch Record) program for all of the technical operations (Extraction/Formulation/Filling) is a primary objective. They are responsible for the overall testing of the extraction and formulation batches and the assurance of purity and purported potency of the commercial products.
Responsible for the CV (Cleaning Validation program) and handling all aspects of the CAPA (Deviation and corrective action) process.
This role would also be responsible for the tracking/control of any controlled substances and responsible for any such reporting to the proper agency.