Manufacturing Associate

Production Compliance

SOP preparation and revision

Change Control Management System

Manufacturing Investigation and Compliance

Data preparation

Power point Presentation

Monthly review meeting

Master document (BMR, BPR, Protocol etc.) review and approval

preparation of Risk Assessment

Initiation and monitoring of Contineous Improvement Projects
- Production Compliance
- SOP preparation and revision
- Change Control Management System
- Manufacturing Investigation and Compliance
- Data preparation
- Power point Presentation
- Monthly review meeting
- Master document (BMR, BPR, Protocol etc.) review and approval
- Preparation of Risk Assessment
- Initiation and monitoring of Contineous Improvement Projects- Few more responsibilities-
- 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.