Attend and ensure the training as per training schedule and TNI
Work according to standard operating procedures in sterile manufacturing department
Prepare, review, revise and control the Standard Operating Procedures of General Area in Sterile Manufacturing Department
Prepare BPR
Validate and calibrate all equipment and lines
Record and check all the logbooks related to general area and equipment of packaging and inspection area
Train all the subordinates, technicians and operators of the department
Comply with cGMP, Good Document Practice and departmental discipline
Handle document of Packing and Inspection
Monitor all the activities related to packing and inspection
Skills:
Preparing for regulatory inspections (USFDA, WHO, EU, etc.).
Keeping documents and areas audit-ready at all times.
Familiarity with quarantine, rejected, and returned goods handling
M.Sc. / B. Pharm / M.Pharm
