Time and Venue
11th Jan - 12th Jan, 11 AM onwards
EU- GMP, Certified, Plot No. E27/1 E27/2, MIDC. Mahad, Village -Jite, Dist. Raigad Titan Laboratories Pvt Ltd
Kindly Carry Salary Documents
Finished Formulation
Time : 11 :00 am to 4:00 pm
Note: Same day selection Kindly Carry Salary Documents
2 - 8 Years Experience Must- (Only Male candidate Preferred Pharma Background) )
1) HPLC 21 CFR Compliance System Handle
2. Instrument handling like, HPLC / Dissolution / UV / IR / GC etc.
3. Maintain the Reserve samples and their quality review.
4. Handling of General SOP's and Operating procedures of Analytical Instruments, Calibrations of Instruments.
5. To maintain documents as per EUGMP, WHO-GMP, c GMP. MHRA, USFDA, TGA, TPD etc.
6. Candidate should have good understanding of subject matter.
7. Candidate should face the audit like EUGMP, MHRA, USDFA, TGA etc
8. Candidate Should have good communication skills.
2. Instrument handling like, HPLC / Dissolution / UV / IR / GC etc.
3. Maintain the Reserve samples and their quality review.
4. Handling of General SOP's and Operating procedures of Analytical Instruments, Calibrations of Instruments.
5. To maintain documents as per EUGMP, WHO-GMP, c GMP. MHRA, USFDA, TGA, TPD etc.
6. Candidate should have good understanding of subject matter.
7. Candidate should face the audit like EUGMP, MHRA, USDFA, TGA etc
8. Candidate Should have good communication skills.
QA:
Responsible for Implementation and ensuring of the process is compliance with BMR, SOPs,
GDP Implementation.
Responsible for Handling, Monitoring, Planning and execution of activities related of IPQA
shop floor activities (Dispensing, Granulation, Blending, Compression, Capsule filling, Coating
and Inspection).
Responsible for giving Line clearance from Product to Product & Batch to Batch change over
according to standard operating procedures for start of various Manufacturing Operations
Responsible for Verification of Allocated Expiry date.
Responsible for performing in-process checks.
Responsible for Calibration of IPQA Instruments.
Responsible for performing AQL (Acceptable Quality Limit) for Tablets and capsules after
completion of batch.
Responsible for execution of process validation, cleaning validation, Equipment validation, Hold
time study and stability study as per the protocol.
Responsible for execution of sampling at all stages as per process validation, cleaning validation,
To collect the Swab samples for Chemical & Detergent as per the sampling plan.
Ensure that Assay Calculation at dispensing stage and ensuring that the materials are dispensed
as per the standard quantities mentioned in the BMR.
Responsible for Yield calculations at different stages of manufacturing to ensure process loss
with respect to each stage.
Responsible for review of Quality records of Engineering, Warehouse & Production
records.
Responsible for Preparation and review of SOPs, BMRs, Protocols.
Responsible for review of Batch manufacturing record.
Responsible for dispatch the final packed product to respective market.
Responsible for handling of deviation and change control.
Responsible for handling of Equipment Performance Qualification, Breakdowns and PMP.
Coordinate effectively with Manufacturing, Store, QA, QC and Engineering departments
GDP Implementation.
Responsible for Handling, Monitoring, Planning and execution of activities related of IPQA
shop floor activities (Dispensing, Granulation, Blending, Compression, Capsule filling, Coating
and Inspection).
Responsible for giving Line clearance from Product to Product & Batch to Batch change over
according to standard operating procedures for start of various Manufacturing Operations
Responsible for Verification of Allocated Expiry date.
Responsible for performing in-process checks.
Responsible for Calibration of IPQA Instruments.
Responsible for performing AQL (Acceptable Quality Limit) for Tablets and capsules after
completion of batch.
Responsible for execution of process validation, cleaning validation, Equipment validation, Hold
time study and stability study as per the protocol.
Responsible for execution of sampling at all stages as per process validation, cleaning validation,
To collect the Swab samples for Chemical & Detergent as per the sampling plan.
Ensure that Assay Calculation at dispensing stage and ensuring that the materials are dispensed
as per the standard quantities mentioned in the BMR.
Responsible for Yield calculations at different stages of manufacturing to ensure process loss
with respect to each stage.
Responsible for review of Quality records of Engineering, Warehouse & Production
records.
Responsible for Preparation and review of SOPs, BMRs, Protocols.
Responsible for review of Batch manufacturing record.
Responsible for dispatch the final packed product to respective market.
Responsible for handling of deviation and change control.
Responsible for handling of Equipment Performance Qualification, Breakdowns and PMP.
Coordinate effectively with Manufacturing, Store, QA, QC and Engineering departments
Production:
1. Responsible for Operation and cleaning of Extruder and spheronizer, Tray dryer, Coating Pan
2. Responsible for granulation activity, Operation and cleaning of RMG, FBD, Multimill.
3. Responsible for NPS coating, Operation and cleaning of FBE (Top spray/Bottom Spray)
4. Responsible for Compression of Tablets, having a sound knowledge of single and Bilayer tablet, Operation and cleaning of Cadmach, Cadpress machine 37 stn and 49 stn, Knowledge of PLC.
5. Responsible for Coating of Tablets, Having Knowledge of Autocoater, Coating of Film coating, Sugar Coating, Enteric coating, Knowledge of PLC.
6. Cleaning and sanitization activity
7. Regular inprocess and daily work execution
8. Responsible for filling of daily entries of area cleaning, BMR, Temperature Humidity.
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