Manage day-to-day operations of lyophilization and aseptic production lines. Ensure compliance with cGMP , FDA , EMA , and other regulatory. Oversee equipment preparation , cleanroom operations , sterile filtration Oversee API manufacturing processes
knowledge of GMP guidelines, CAPA, deviations, change control. Handling SOPs, batch records, validation protocols, audits, regulatory inspections, aseptic practices. Equipment, process, cleaning, and method validation expertise.