FDC Limited, This campus has multi product Tablet and Capsule manufacturing facilities. It has a State-of-the-Art Pilot plant for manufacturing Exhibit batches for Regulated Markets. This facility has been successfully inspected by UKMHRA, W.H.O, NDA-Uganda & PPB- Kenya. The products manufactured are exported to Europe, CIS, Asia-Pacific and African countries.
FDC Limited – Walk-In Interview on 3rd Dec’ 2023 for Production / Quality Control / Quality Assurance at GOA
Officer – Quality Assurance – 2-5 yrs Exp.
- To verify and certify line clearance of critical operations, check online records & critical steps of manufacturing and packing operation and to carry out in process checks.
- To ensure all instruments are calibrated and validations are carried out in timely manner. To identify and report the non-compliances observed in individual departments.
- To issue Batch Manufacturing Record, Batch Packing Records & logs.
- Issuance of additional BMR & BPR pages.
- To Issue, Review & Maintain Change Control of Site, Corporate & their respective logs.
- To issue controlled copies and retrieval of old RMS, FPS, SPS, PMS, RM & PM Item Code List.
- To issue Validation Protocol, Method Validation Protocol, URS & Qualification as per the schedule.
- To verify and certify line clearance of critical operations.
- To check online records.
- To check critical steps of manufacturing and packing operation and to carry out in process checks.
- To ensure all instruments are calibrated and validations are carried out in timely manner.
- To withdraw samples for analysis at intermediate and finished product stage.
- To monitor steps followed in manufacturing and packing are as per standard operating procedure.
- To carry out sampling of process validation samples/ cleaning validation swab and rinse samples.
- To review and compile complete batch records (BMR and BPR) prior to release.
- To identify and report the non-compliances observed in individual departments.
- To withdraw Stability & Reference Samples.
- To compile Product Quality data.
- To issue controlled copies & retrieval of old SOPs and QAPs.
- Handling of Deviations & CAPA.
- Handling / investigation of product complaints, incident reports, batch failures and product recalls.
- Updation of MLD’s.
- Preparation, Updation, issuance, retrieval of Price list.
- Document submission as per Regulatory requirement.
- Any other assignments allocated by Unit QA from time to time.
Related Jobs: TORRENT PHARMA – Walk-In Interviews on 3rd Dec’ 2023 for Manufacturing / Technology Transfer / QA / QC / Packaging / Procurement
Senior Officer – Quality Control – 3-6 Yrs Exp.
- Analytical work record for analysis, perform Raw Material & Finished product analysis as per current specification, maintain analytical records as per GLP requirements. Knowledge of HPLC/GC/IR/UV a must.
- Analysis of raw material , finished product and stability samples by HPLC and chemical method
- Knowledge of GLP, GDP and GxP.
- Knowledge of LIMS and SAP
- Standardization and Re-standardization of volumetric solution.
- Knowledge of Other QC instruments like dissolution, GC, AAS etc
- Daily pH Calibration & record of pH Calibration Certificate.
Senior Officer – Production
- Tablet manufacturing exp, Knowledge of Primary and Secondary area, Exposure in Regulatory audits, Basic operative knowledge of Blister pack machines/documentation. Granulation/Compression/Coating in tablet section.
- To implement and follow loading chart as per monthly production plan.
- To give request to Q.A. for BMRs / BPR’s as per schedule.
- To coordinate with stores for availability of RM.
- To coordinate with QA, QC, Stores for any change in schedule.
- To do calculation of ingredients as per BMR and get it authorized from QA/QC.
- To carry out Dispensing activity as per BMR.
- To carry out various manufacturing activities like Granulation, compression, Coating, Visual
- inspection as per BMR.
- To have a proper control on status labeling at each stage of manufacture as per QAP/SOP.
- To ensure that environmental conditions, as specified are achieved and maintained in the
- respective areas.
- To ensure that Purified water of specified quality is used in the manufacturing activities.
- To ensure Proper storage of products at every stage as per specifications.
- To document and maintain the necessary logs as per procedure.
- To carry out qualification of new equipments and documentation of same.
- To carry out process validation and documentation of same.
- To prepare SOP for new equipment/ process/activity.
- To revise SOP’s as per requirement.
- To make purchase indents for items like FBD bags, Food Grade oil/Grease, Sieves/Screens, Punches & Dies and other consumables and to ensure that required inventory of these items is maintained.
- To get the equipment defect rectified, missing parts replaced and keep all the equipments in
- good running condition at all the times.
- To prevent and control any damage to doors, windows, cupboards, floor, ceiling,
- and any other part of the facility, internally as well as externally.
- To maintain cleanliness and hygiene at work place.
- To ensure that proper attire and dress code is followed in the department.
- To maintain safety of product, self and machine at work place.
- To maintain Good conduct and discipline in the department.
- To carry out training and guidance to production supervisors.
- To report any deviation, untoward incident, accident to the superior.
- To ensure that products manufactured are of quality as specified.
- To assure all the entries done in SAP.
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Asst. Manager – Production
- 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.
- Date: 3rd December, 2023
- Time: 9.30 AM – 3.00 PM
- Venue: FDC Limited, Plant III – Phase III/A, Plot No. L-121/B, Salcette, Verna Industrial Estate, Verna, Goa 403722
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