- Should have knowledge of Water System, HVAC, Tableting machinery and instruments, responsible for the up-keep of the production facility and the equipment/instruments, handle deviations, change controls, CAPAs related to Production. Qualifications & Validations of the new equipment & existing equipment etc.
- FDA approved desirable
1. Production Planning/ Control/ Monitoring
1.1 Planning of production activities as per the requirement and guiding the subordinates in execution of the same.
1.2 Attend to daily production/coordination meeting.
1.3 Attend to monthly inventory meeting.
1.4 Attend to monthly QMS meeting.
2. Manpower control and monitoring
2.1 Planning of manpower requirement based on production plan.
2.2 To conduct interviews and selection of the personnel.
2.3 Controlling of men movement in the department.
3. Equipment control and monitoring
3.1 Selection of new equipment.
3.2 Authorization for carrying out preventive maintenance of equipment and utilities.
3.3 Verification of preventive maintenance activity after completion of the same.
3.4 Checking of calibration of weighing balances.
3.5 Checking of Calibration of DT apparatus.
3.6 Checking of Calibration of Friability tester.
3.7 Checking of Calibration of moisture analyzers.
3.8 Sieve/ screen integrity checking.
3.9 Punch and Die inspection check Review.
4. Coordination and follow-up
4.1 To coordinate with different departments like R&D, PDD, Purchase, Costing, IT, Planning etc. at HO.
5. Technology transfer
5.1 Critically monitoring of scale up batches.
5.2 Critically monitoring of initial validation batches.
5.3 Review of tech transfer documents.
6. Trainings and personnel development
6.1 Conducting survey to identify training needs for ATP.
6.2 Preparation/updation of training matrix.
6.3 Preparation of training module/presentations as per topics of ATP.
6.4 Preparation of training questionnaires.
6.5 Conducting of classroom/shop floor trainings as per ATP schedule.
6.6 Evaluation of trainings.
6.7 Review of training records.
6.8 Monitoring of training effectiveness and identify gaps in training.
7. Environment safety and facility upkeep
7.1 To check that safe working environment prevails at workplace.
7.2 To check that all safety norms are followed and recommended PPE’s are used at workplace.
7.3 Review of facility upkeep and maintenance –checkpoints.
7.4 Review of compliance to facility upkeep and maintenance checkpoints.
7.5 Review of detailed report of EMS of Zone I/II/III/IV.
7.6 Review of Alarm history report of EMS.
7.7 Review of trends of EMS.
7.8 Review of detailed report of PWS.
7.9 Review of Alarm history report of PWS.
8. System control and monitoring –SAP
8.1 Request for new SAP user ID to corporate IT dept.
8.2 Detailed training of new users of SAP system in both quality and production server.
8.3 Periodic training on SAP.
8.4 Monitoring of training effectiveness in SAP.
8.5 Trouble shooting/guidance in SAP transactions.
8.6 Performing SAP transactions as per authorizations.
8.7 Template creation for resource master.
8.8 Creation of Product master in SAP – Recipes.
8.9 Creation of Product master in SAP – Production Versions.
8.10 Request for SCE to costing dept.
8.11 Checking of SAP transactions performed by diff users.
8.12 Checking of planned orders after MRP run.
8.13 Testing/checking of newly developed transactions in SAP and subsequently imparting training to all concerned with monitoring effectiveness.
8.14 Identification of gaps in SAP and suggestions for up gradation/improvement.
9. Document reviews
9.1 Review of master documents – MFR, BMR, BPR.
9.2 Review of master documents – Process Validation protocol, Equipment Qualification protocols.
9.3 Review of master documents – Cleaning Validation protocol.
9.4 To raise/review planned and unplanned deviations and do the tracking of the same till they are closed.
9.5 To carry out detailed investigations in cases of unplanned deviations.
9.6 To carry out detailed manufacturing investigations in cases of OOS/ OOT of semi-finished / finished product.
9.7 To carry out detailed manufacturing investigations in cases of OOS/ OOT encountered during stability testing.
9.8 To carry out detailed manufacturing investigations in cases of market complaints/recalls.
9.9 To raise/review change controls and do the tracking of the same till they are closed.
9.10 Risk assessment studies.
9.11 Review of SOP’s.
9.12 Review of filled BMR’s.
9.13 Random review of departmental logs.
10. Shop-floor Governance
10.1 To check that the products are manufactured and stored as per specification.
10.2 To check that proper environmental conditions are maintained in the dept.
10.3 To check all the production records thoroughly before they are sent to the QA department.
10.4 To check that the Area and equipment are maintained in good condition.
10.5 To check that discipline and safety is maintained in the department.
10.6 To check that proper sanitation and hygiene practices are followed at workplace, change rooms and canteen.
10.7 To guide the shop-floor team in all the aspects of production activities.
