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Entry into the department before shift time:
Report to HOD and reliever.
With HOD and reliever discuss:- Special requirement/ instruction/target, last 2 shift issues, another 3 shifts schedule and additional task if any.
Take quick round with the reliever in the entire area:-During round try to touch each and every people and have some specific question may be which are most critical to last 2 shifts issues/area etc.
Charge will be taken during round physically area:-Any abnormality observed need to be objected; also information should got to HOD. Abnormality should cleared by the doer before leaving the work place.
Come to planning board well advanced (before shift start) and see the schedule status on the board updated and people reporting in the shift on time.
Stand at the entry point and ensure:-
Everybody reports on time at work place and charge handover happening at work place only.
Operator handover running machine to the reliever.
Proper allocation of part time and full time employee considering absenteeism if any.
Ensure each and every individual should know the shift plan and what to deliver in the shift before going to work place. It should be predefined and changes can be only re-communicated.
Again discuss in depth with all concerns(reliever, HOD, department planner, PM dispensing person and misc. responsibilities persons)for schedule, investigation and CAPA to issues, productivity, quality issues documents and department works to perform in this shift, this is your understand for pre and post 3 shifts.
Report to the concern work place:
Instruct off line/ concern people to make arrangement of PM/SFG and any other materials for coming two shift operations.
Make responsible off line/concern people to close quality issues, perform quality activity and other misc. activities (Like-BPR/BMR, JDE, FG, SMR, Training & other arrangements).
After engaging all off line people and understand the requirements start taking round in all area and concerns of the department.
Batch manufacturing/Manufacturing:
During round ensure:-
People, quality systems, machine, accessories, documents, materials and all other things are in place. Ensure things are in their designed place and vice versa.
Interact with line people (Supervisor, Operator) and understand that they know todays target for output and quality.
Ask few casuals that they should know what they are doing and our requirement. Ensure training record of casual if any.
Perform critical challenge test and In process checks. Ensure no machine functioning parameters/facility by passed. Talk the same with line people simultaneously.
Check the line documents entries(BPR/BMR, Log books and any formats).Cross verify with 3rd eye that correct document, product and MP used.
Ensure and discuss with people that if any special precaution(Like staggering during breaks, sensitive product, new product, new PM, new market, off line activity, special/critical product, new MP, machine issues etc.
Get pending work from previous shift, get it done from them only.
Go through the BPR/BMR, PM and machine and ensure correct dose and material used.
Evaluate and challenge the working of MP for correctness and if required retrained them.
Ensure no human intervention at any places and correct procedure being followed.
Check people should known the batch completion time, SFG quantity, What yield batch will give etc.
Must be consider for the following:
After completion of round in department report finding to the HOD.
No documentation NCs and manipulation on dose and process.
Keep required MP on the line.
Focus the improvements project like Yield, Quality, safety, Cost saving and Man hour reduction.
All report must be completed like Shift report, DPR etc.
Safety, hygiene, discipline and ISO requirements followed in the department.
Ensure everybody in shift follow their responsibility.
Spend some time for innovation and initiatives in the department.
Spend time to trained the people.
Spend time on other department activities like procurement, change parts, other department issues, meeting and discussion.
Ensure people should report and taking permission for each non routine jobs.
Do not allow else to the job not who are not assigned and not recorded.
Spend some time for personal talks with people about him and family.
Ensure activities are on- line.
Supervisor should on the line every time. For any help he should talk to supporting team allocated on the line or Shift in charge.
Face abnormality and talk to HOD immediately.
Ensure and pass communications in such way that nobody should miss of partial communications shall not be transferred to other shift people.
Ensure special precaution in night shift so that people should not sleepy.
Ensure MP allocated for each and every activity (Like operational lines, wash area, change parts, PM staging, HK etc.) and the same recorded in the log book.
Shift end review with individual for quality output and other data.
Be ready to give time to next shift reliever and to take round with him.
To follow the procedures pertaining to the environmental management system.
To support in implementation new procedure related to environment management system.
To report any observation / non-conformance related to the environment management system
To follow and maintain 5s in work place.
Technical Assistant for manufacturing department
Official account of Jobstore.
Sr Technical Assistant for Manufacturing (Granulation area)
Official account of Jobstore.
1-Having knowledge about capsule filling machine and standard operating procedure and cleaning procedure
2-On line GMP related documentation.
3-Batch reconciliation and balance calibration with daily verification.
4-Knowledge about change parts of capsule filling machine.
Exposure in US-FDA audit
Official account of Jobstore.
1-Having knowledge about capsule filling machine and standard operating procedure and cleaning procedure
2-On line GMP related documentation.
3-Batch reconciliation and balance calibration with daily verification.
4-Knowledge about change parts of capsule filling machine.
Exposure in US-FDA audit
Official account of Jobstore.
Official account of Jobstore.
1-Having knowledge about capsule filling machine and standard operating procedure and cleaning procedure
2-On line GMP related documentation.
3-Batch reconciliation and balance calibration with daily verification.
4-Knowledge about change parts of capsule filling machine.
Having knowledge about regulatory audit US-FDA
Official account of Jobstore.
To verify/handle all the rejection as per BPR instruction/respective SOP.
To responsibility for follow the Good Documentation Practice on shop floor.
To carry out the activity whenever assigning by the Shift in charge/management based on the company requirement.
To follow the procedures pertaining to the environmental management system.
To support in implementation of new procedure related to environment management system.
Report any observation / non-conformance related to the environment management system.
Responsible in 5S related activities.
Responsible to perform the supervisor activity for cleaning, line clearance and dispensing during routine operations.
Official account of Jobstore.
1-Having knowledge about capsule filling machine and standard operating procedure and cleaning procedure
2-On line GMP related documentation.
3-Batch reconciliation and balance calibration with daily verification.
4-Knowledge about change parts of capsule filling machine.
Exposure in US -FDA audit
Official account of Jobstore.
Official account of Jobstore.
Charge will be taken during round physically area:-Any abnormality observed need to be objected; also information should got to HOD. Abnormality should cleared by the doer before leaving the work place.
Come to planning board well advanced (before shift start) and see the schedule status on the board updated and people reporting in the shift on time.
Stand at the entry point and ensure:-
Everybody reports on time at work place and charge handover happening at work place only.
Operator handover running machine to the reliever.
Ensure each and every individual should know the shift plan and what to deliver in the shift before going to work place. It should be predefined and changes can be only re-communicated.
Again discuss in depth with all concerns(reliever, HOD, department planner, PM dispensing person and misc. responsibilities persons)for schedule, investigation and CAPA to issues, productivity, quality issues documents and department works to perform in this shift, this is your understand for pre and post 3 shifts.
Report to the concern work place:
Instruct off line/ concern people to make arrangement of PM/SFG and any other materials for coming two shift operations.
Make responsible off line/concern people to close quality issues, perform quality activity and other misc. activities (Like-BPR/BMR, JDE, FG, SMR, Training & other arrangements). After engaging all off line people and understand the requirements start taking round in all area and concerns of the department.
Batch manufacturing/Manufacturing:During round ensure:-
People, quality systems, machine, accessories, documents, materials and all other things are in place. Ensure things are in their designed place and vice versa.
Interact with line people (Supervisor, Operator) and understand that they know todays target for output and quality.
Ask few casuals that they should know what they are doing and our requirement. Ensure training record of casual if any.
Perform critical challenge test and In process checks. Ensure no machine functioning parameters/facility by passed. Talk the same with line people simultaneously.
Check the line documents entries(BPR/BMR, Log books and any formats).Cross verify with 3rd eye that correct document, product and MP used.
Ensure and discuss with people that if any special precaution(Like staggering during breaks, sensitive product, new product, new PM, new market, off line activity, special/critical product, new MP, machine issues etc.
Get pending work from previous shift, get it done from them only.
Go through the BPR/BMR, PM and machine and ensure correct dose and material used.
Evaluate and challenge the working of MP for correctness and if required retrained them.
Ensure no human intervention at any places and correct procedure being followed.
Check people should known the batch completion time, SFG quantity, What yield batch will give etc.
After completion of round in department report finding to the HOD.
No documentation NCs and manipulation on dose and process.
Keep required MP on the line.
Focus the improvements project like Yield, Quality, safety, Cost saving and Man hour reduction.
All report must be completed like Shift report, DPR etc.
Safety, hygiene, discipline and ISO requirements followed in the department.
Ensure everybody in shift follow their responsibility.
Spend some time for innovation and initiatives in the department.
Spend time to trained the people.
Spend time on other department activities like procurement, change parts, other department issues, meeting and discussion.
Ensure people should report and taking permission for each non routine jobs.
Do not allow else to the job not who are not assigned and not recorded.
Spend some time for personal talks with people about him and family.
Ensure activities are on- line.
Supervisor should on the line every time. For any help he should talk to supporting team allocated on the line or Shift in charge.
Face abnormality and talk to HOD immediately.
Ensure and pass communications in such way that nobody should miss of partial communications shall not be transferred to other shift people.
Ensure special precaution in night shift so that people should not sleepy.
Ensure MP allocated for each and every activity (Like operational lines, wash area, change parts, PM staging, HK etc.) and the same recorded in the log book.
Shift end review with individual for quality output and other data.
Be ready to give time to next shift reliever and to take round with him.
To follow the procedures pertaining to the environmental management system.
To support in implementation new procedure related to environment management system.
To report any observation / non-conformance related to the environment management system
To follow and maintain 5s in work place.
NA
Official account of Jobstore.
Technical assistant for compression department.
Official account of Jobstore.
· 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.
Official account of Jobstore.