Day-to-Day Responsibilities
Keeps the plant up to date with cGMP norms, Schedule M requirements and the Drugs and Cosmetics Rules that apply to its products.
Reviews standard operating procedures (SOPs), batch records and change controls to check that work follows approved procedures.
Plans and runs internal GMP audits, then tracks corrective and preventive actions (CAPA) until each one is closed.
Prepares documents and answers queries during inspections by CDSCO, state drug authorities and foreign regulators such as USFDA.
Investigates deviations, out-of-specification results and complaints together with the quality control and production teams.
Trains production, quality and warehouse staff on compliance rules, documentation and data integrity.
Tracks licence renewals, approvals and regulatory submissions so that none of them lapse.


