· 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.