Job description
Be the First to Apply 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
- 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 new 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 clearance during batch change over.
- In process testing as defined in Batch Manufacturing Record.
- Preparation of Material Return Note (MRN), Material Requisition Note (MRQN), Line rejection Note (LRN) of Processing area.
- Review the Batch Manufacturing and other quality documents. Essential Qualification B.Sc / B. PharmaFull time