Experience

My Responsibility’s in this company

• Water treatment plant

1. Operating, Maintenance and Supervision of Water system including Pre-treatment plant & Post- treatment plant like Multi grade filter (MGF), Softener,Reverse osmosis (RO), PW / WFI Distribution Loops,Pure steam generation system (PSG),Multi column distillation plant (MCDP),PW generation system..etc.
2. Good knowledge of water chemistry and monitoring treatment programs for the water before and in-process in order to optimize system performance and meet the required standards as well.
3. Adjust treatment processes and equipment settings as necessary to maintain compliance with regulatory standards.
4. Handling Chemical cleaning,Sterilization,Passivation  & chemical sanitization Activity as per Schedule & standard operating procedure. 
5. Handling hydro test activity & All Schedule activities in the water system.
6. Observes the operation of water pumps, electric motors and chemical feed pumps.
7. Perform routine maintenance and repairs on water treatment equipment, such as pumps, valves, filters, solenoid coil and chemical feed systems.
8. Maintain accurate records of water treatment plant operations, including daily logs, test results, chemical usage and maintenance activities.
9. Generate and maintain the Water System SCADA reports ( Process Value, Audit trail, Alarm, Sanitization Reports ). 
10.  SAP purchase request given for the requirement of spares & chemicals for procurement to Maintain the minimum stock.
11.  Perform regular inspections and tests on water samples to monitor the quality of treated water, including pH levels, chlorine levels, turbidity and other parameters.
12. Analyze data and trends to identify issues or potential improvements in the water treatment process and implement necessary corrective actions.
13. Coordination with other departments (QA, QC, Engineering, Store).
14. Deal & Coordinate with third party vendors and Supervision of Site Activity (Insulation, Fabrication, Calibration, Material Loading-Unloading Work ).

Production area

• Filling area

1. Monitoring and maintaining the equipment operations to comply with production requirements.
2. Safely operates filling equipment and troubleshoots problems to ensure process parameters are met throughout the run.
3. Must prepare filling machine parts following good aseptic techniques to minimize particulate contamination.
4. Aseptic handling and installation of sterilized machine parts.
5. Prior to the production activities verifying the room temperature,RH% and working of camera.
6. Complies with current SOPs and cGMP to maintain aseptic gowning requirements set up and adjusts filling equipment setting to meet process parameters.
7. Unloads autoclave material when cycles are completed and verifies the integrity of loads.
8. Monitoring the filtration process and also performing the filter integrity tests.
9. Practices aseptic technique at all times while working in aseptic Areas.
10. Documents all the activities as per ALCOA principles.
11. Clean and sanitize the fill equipment and aseptic area as per SOP.
12. Attend the media fill process for every six months as per GMP.
13. Following the aseptic personnel and material flow of the filling area as per GMP.
14. Practices aseptic technique at all times while working in aseptic areas.
15. Look after all documents before submitting to the QA.

• Vial washing machine and Dry hot tunnel.

1.  Monitoring and maintaining the equipment operations to comply with production requirements.
2. Safely operates Vial washing machine,Dry hot tunnel and troubleshoots problems to ensure process parameters are met throughout the run.
3. Frequently check and monitor the clarity of waters in the vial washing machine as per BMR. 
4. Perform the integrity test for hydrophilic and Hydrophobic filters.
5. Frequently check and monitor the Preheating,Heating and cooling zone temperature as per BMR. 
6. Documents all the activities as per ALCOA principles.

Utility area

• Steam boiler

1. Operate, maintain and monitor industrial steam boiler to ensure optimal performance.
2. Regularly inspect  the Steam line, condensate line and steam trap to avoid any leakage.
3. Regularly inspect the water level in the Boiler and the condensate tank.  
4. Perform regular inspections and tests on water samples to monitor the quality of water like Hardness, pH levels and other parameters.
5. Perform preventive maintenance of the boiler as per SOP. 
6. Troubleshoot and diagnose system malfunctions and take corrective action.
7. Maintain detailed records of operating and maintenance activities.

•  Chiller

1. Operate, maintain and monitor industrial chillers to ensure optimal performance.
2. Adjust temperatures, pressures, and other settings on chillers.
3. Regularly inspect  the chiller loop.
4. Perform routine inspections to avoid any malfunctions during operation.
5. Maintain detailed records of operating and maintenance activities.
6. Troubleshoot and diagnose system malfunctions and take corrective action.
7.  Perform inspections and tests on water samples to monitor the quality of water like Hardness, pH levels and other parameters.

My Responsibility’s in this company

Sterile powder filling plant(Cephalosporins)(J9):-

1. Monitoring and maintaining the equipment operations to comply with production requirements.
2. Safely operates filling equipment and troubleshoots problems to ensure process parameters are met throughout the run.
3. Prepare filling machine parts following good aseptic techniques to minimize particulate contamination.
4. Aseptic handling and installation of sterilized machine parts.
5. Prior to the production activities verifying the room temperature,RH%, working of camera, verification of weighing scale, stoppering and crimping of empty vials.
6. Complies with current SOPs and cGMP to maintain aseptic

gowning requirements.

7. Preparation of sterile API powder and transfer to the filling

machine by using aseptic techniques.

8. Unloads autoclave material when cycles are completed and

verifies the integrity of loads.

9. Practices aseptic technique at all times while working in aseptic Areas.

10. Documents all the activities as per ALCOA principles.
11. Clean and sanitize the fill equipment and aseptic area as per SOP.

12. Attend the media fill process for every six months as per GMP.
13. Following the aseptic personnel and material flow of the filling area as per GMP.

14. Practices aseptic technique at all times while working in aseptic areas.

15. Look after all documents before submitting to the QA.

Insulin and Glargine Purification unit(J11):-

1) Accountable for involving in downstream processing and

troubleshooting.

2) Release production Recipes, process vessels CIP using

Siemens PCs7 module. Involve in cleaning, sterilization, Leak

test and Integrity test of freeze dryer by communication with

Siemens PCs7.

3) Facilitate Protein purification by ion exchange chromatography by using DAEAE sepharose and Q sepharose Medias.

4) Assist in Protein purification by RP-HPLC by using Kromasil c8 Media.

5) Perform Process optimization for recombinant human insulin

analogue.

6) Carry out liquid filtration of Insulin.

7) Operate and monitor Westfalia protein separator and unloading of crude insulin and pure insulin crystals.

8) Perform Tangential Flow Filtration (Diafiltration) by using a

0.2-micron membrane and Tangential Flow Filtration (Ultrafiltration) by using 5 KD cassettes.

9) Handle final API product during freeze dryer loading and

unloading. 

10) Operate freeze dryer with monitoring temperature,

vacuum and pressure.

11) Operated Autoclave and DHS.

12) Carry out the buffer preparation for the batch as per

requirements.

13) Review, edit, and revise completed batch records,documentation, logbooks, and SOP’s in accordance with cGMP standards.

14) Calibration & verification of pH meter & weighing balance and Maintaining the related records.

15) Responsible for operating and cleaning the equipment,

instrument or accessories used during the routine production

activities as per the SOP.

16) Raise the job request and SAP notification for breakdown

maintenance.

17) Supervision of area cleaning and monitoring.

18) Packing and unpacking of chromatography columns.

19) Perform efficiency tests for chromatography columns to follow safety procedures as required for the job.

My Responsibility’s in this company

➢Producing APIs according to pre-approved BMR instructions.
➢Ensuring all production batch records,equipment usage log is completed on-line with signature.
➢Responsible to verify / countersign the applicable documents related to PPZ and Wet Manufacturing areas.
➢Coordination with the Engineering department for ensuring maintenance related works.
➢Coordination with QA for the requirement of Batch Manufacturing Records.
➢If any Deviation absorbed against established Procedures, the same shall be reported immediately to shift in-charge/ supervisor.
➢Documentation of GMP, QMS and EMS related activities like handling of Hazardous and Non-hazardous waste, Corrective and Preventive action.
➢Perform the necessary calibrations and record the details in respective registers with signature.
➢Ensuring GMP compliance in plant, Maintaining of documentation activities as per good documentation practices.
➢Operation and cleaning of equipment like Reactor, Centrifuge, Rotocone vacuum Dryer, Vacuum Tray Dryer, Sparkler filter, Reverse Osmosis, Multi mill, Polypropylene column, Storage vessels and their documentations.

➢Operation and Cleaning of Powder Processing Zones of equipment like Rotocone Vacuum Dryer, Vacuum Tray Dryer, Multi Mill, Fluid Bed Dryer, Jet Mill, Blender and their documentations.
➢Perform the Packaging activities as per instruction as applicable.
➢Responsible for performing any other activities assigned by HOD / Designee on time to time, after the completion of relevant training.