Chemistry Manufacturing and Controls
GMP and QSR implementation and oversight.
Preparation of Engineering/Production Facility Plans.
QC specifications and test method development and validation.
Preparation and/or review of manufacturing documentation including master production records (MPRs), QC testing records, stability and qualification/validation protocols and reports, forms and SOPs.
Author written procedures for the manufacturing process, including instructions for equipment use, environmental monitoring, calibration, and maintenance of equipment, etc.
cGMP compliance audits of systems, facilities, and process/operations of suppliers, vendors, and contractors, CMOs including, GMP testing facilities, API and finished product manufacturing facilities, labeling and packaging facilities, holding and distribution facilities/clinical supplies.
Review and approval of executed production records (EPRs), QC data and certificate of analysis, product disposition, development and stability reports.
Advise on QA Material/Product Disposition.
QA monitoring and controls development and implementation in order to reduce the number of defects and improve levels of quality and optimize efficiency.
Preparation/review of CMC sections of regulatory submissions (i.e. INDs, NDAs, BLAs, DMFs, etc.).
Stability Protocol evaluation and review of results and reports.
Production staff training on quality procedures, protocols, and documentation.
Deviation Investigation.
Leadership and oversight of validation activities.