Responsible/ Machine Operation for Granulation activity like HSMG, FBE/ Blender etc. and Compliance.
- To ensure 100% safe operation in production area, follow SOPs, proper earthing, additional precautions for solvent, people to know firefighting training and use of fire extinguisher.
- Ensure all the necessary PPEs are available in production facility and monitor proper PPEs are worn by the personnel's during manufacturing and packaging operation.
- Reporting the near misses and ensure their compliances.
- Follow ISO 14000 practices
- To follow and maintain 5s in workplace.
- Handling of waste generated in manufacturing area as per SOP.
- No critical/major observations in GMP regulatory audit i.e., internal/external.
- cGMP Compliance in entire manufacturing area and SOP compliance on all aspects.
- Zero overdue on Training.
- Follow ALCOA and ready for any time inspection.
- Maintaining of manufacturing area with zero defects.
- Achieve weekly plan schedule NLT 90%
- Maintaining of equipment's and to reduce the breakdown time by maintaining spare part, proper PMP.
- Involved in the dispensing of raw materials.
- Storage and material movement of dispensed materials
- Verification of dispensed materials against the batch card.
- Verification of in process storage materials to its product name, batch number container number etc. against batch card in each stage.
- Maintaining of machine, accessories, documents, area, materials, and all other things are in place. Ensure things are in their designed place and vice versa.
- Perform critical challenge test and in process checks. Ensure no machine functioning parameters/facility by passed.
- Ensure and discuss with people that if any special precaution (Like staggering during breaks, sensitive product, new product, new PM, new market, offline activity, special/critical product, new manpower, machine issues etc.).
- Preparation and storage of disinfectant solution and cleaning agents.
- Cleaning of production area and machine.
- Involved in the Line clearance production area.
- Issuance and integrity checking of sieves, screens, FBE bags etc.
- Cleaning and checking of tools before and after completion of batch.
- Cleaning and storage of HDPE containers.
- Indenting, storage, issuance, usage, and destruction of silica gel.
- Prevent the cross contamination during manufacturing.
- Execution of necessary document during cleaning and line clearance & BMR.
- Proper operation and setting of machines to minimize the spillage and rejection.
- Performance of in process check and challenge test as per BMR and if any abnormalities observed inform to the superior and QA.
- Involved in the Equipment PMP activities along with engineering person.
- Monitoring of Environmental condition and reporting maintenance team if any abnormalities noticed.
- Ensuring calibration of instruments as per the calibration schedule.
- To give Training to junior level operators and newly joined persons.
- Active participation in Yield improvement project or another assigned project.
