Job Description
Technical Staff - ProductionJob Description
Well-versed in sterile product manufacturing techniques, including drug manufacturing, autoclaving, FFS (Form–Fill–Seal) filling, aseptic filtration, and other processing operations. Responsible for executing manufacturing activities in the Sterile Department on a shift-to-shift basis and completing all documentation in accordance with cGMP requirements.
Key Responsibilities
Key Roles/Responsibilities: - Allocates workmen for different workstations on shift-to-shift basis. - Ensure no stoppage of operation / machines due to non-availability of manpower and any kind of machine breakdown. - Supervises the line operations and participate in Validation activities as per the protocol. - Maintains c-GMP practices along with documentations in various records. - Involvement in the processing and documentation of trial batches. - Fills and checks BMR before submission to the superiors. - Handles minor parametric setting issues in various machines and products.
- Monitors speed of machine and output according to the run time. - Imparts on job/ Classroom training to the concern workmen and supervisor for SOP and cGMP systems. - Imparts induction activity to all current joining. - Monitors and reports the unauthorized movement of workmen from line. - Takes up the responsibilities of the immediate supervisor for the section in his absence. - Helps section in charge in preparation of SOP. - Reports on day-to-day basis activities in SAP system. (If SAP user id is available) - Verifies the balances on daily and monthly basis. - Participate in machine qualification activities. - Checks all the calibration tags of equipment, instruments and fire extinguisher for their due date time to time. - Knowledge and involvement in Daily Management System. - Knowledge and involvement in ISO 14000 & 13485. - Any other activity from time to time which his supervisor / company feels appropriate. - Checking of line clea