To ensure cGMP compliance requirement as per Schedule M, WHO, other MO and regulated market guideline.
Prepare and review of SOP, test protocols, reports, BMR/BPR/MFR, qualification protocol/report and other relevant document required for execution of manufacturing.
Execute and monitor batch manufacturing and packing related all documents like batch record, logbooks, etc.
Risk management and mitigation strategies for product manufacturing/packing activities.
Execute trouble shooting, process improvisation and manufacturing activities as and when required.
Prepare QMS documents like CCF, Deviation, Investigation, NCR, Risk Assessment, etc.
Plan and execute manufacturing/packing activities as per product planning schedule.
Organizing and impart trainings to the staff members.
Project and resource management.
Ensure smooth technology transfer and product transfer activities.
Supervise the manufacturing/packing activities in line with cGMP requirement.
