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2.0 - 9.0 years
5 - 6 Lacs
baska
Work from Office
Practical / testing Work experience in Quality Control lab (Preferably parenteral formulation) Hands-on experience on laboratory software like LIMS , Trackwsie, Empower etc. Work Experience on Review of analytical raw data Work experience on handling of laboratory investigation i.e. OOS/Lab Event /UPD investigation Knowledge on GLP/GMP/GDP requirement Knowledge and experience on Audit trail review of analytical software s in lab Ready to work in Shift schedule Good Communication skill
Posted 1 week ago
2.0 - 5.0 years
3 - 4 Lacs
Baska
Work from Office
Execution of IQ, OQ and PQ for new equipment, facility & utility system, report preparation and maintenance of record. Execution of Periodic performance verification activities for equipments, facility, utilities and its report preparation. Review Initial qualification master document like URS, GxP assessment, DQ, FAT, SAT, IQ, OQ, PQ and PPV of EFU system and all executed report. Handling of departmental QMS activity through track wise software, discrepancy / deficiency activity compliance of observation, summary preparation for regulatory submission. Qualification and Periodic performance verification activity execution, compilation, review of reports [Filter integrity test (PAO), air velo...
Posted 1 month ago
1.0 - 5.0 years
3 - 3 Lacs
Baska, Vadodara
Work from Office
Department: Microbiology Role: Environment Monitoring Role & responsibilities To perform environmental monitoring in production area by passive air sampling, active air sampling and surface monitoring. To perform personnel monitoring. To operate Lonza Moda Software. To perform plate issuance, transfer of EM sampling kit to production area and vice versa and plate incubation activity.
Posted 2 months ago
0.0 - 1.0 years
1 - 2 Lacs
Baska
Work from Office
Role & responsibilities (Production): Assist in manufacturing operations of parenteral dosage forms (sterile injections) as per SOPs and GMP guidelines. Monitor and record process parameters during manufacturing and filling operations. Ensure compliance to cGMP, documentation and data integrity norms. Support continuous improvement initiatives in production efficiency and compliance. Role & responsibilities (Engineering): Assist in preventive maintenance and breakdown handling of production equipment Support engineering team in equipment qualification and calibration activities. Monitor Utility systems Maintain proper documentation as per GMP norms. Follow safety protocols and support new in...
Posted 2 months ago
3.0 - 8.0 years
1 - 6 Lacs
Guwahati, Dahej, Dadra & Nagar Haveli
Work from Office
Computer System Validation, QMS and IT
Posted 3 months ago
2.0 - 6.0 years
2 - 7 Lacs
Baska
Work from Office
For Production : Exposure pertaining to groninger vial filling , groninger bottle filling, fedegari autoclave, NKP vial filling machine, lyophilizer , spray dryer , aseptic process, complex manufacturing, exposure to CIP/SIP, skid manufacturing, pre filling syringe , QMS is required. Experience required is 2-6 yrs. For Engineering : Should to preventive/ breakdowns maintenance of sterile manufacturing plant, maintenance of autoclave, filling machine - vial, bottle, ampoule, ophthalmic, lyophilizer, freeze dryer machine , BFS machine is required. Experience required is 2- 6 yrs. Job Location : Sun Pharmaceutical Medicare Limited : Nr. Hotel Sarvottam, Survey NO 22 & 24 , Village : Ujeti , Pos...
Posted 3 months ago
0.0 - 2.0 years
2 - 3 Lacs
Baska
Work from Office
Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation. To ensure that product is produced and stored according to the appropriate documentation in order to obtain the desired quality. Responsible for Review comments of MF, FMEA, RA protocol (Sampling plan, Process validation protocol) and compliance. Handling Support of Trouble shooting batches for data comparison and route cause Investigation at...
Posted 3 months ago
6.0 - 11.0 years
5 - 6 Lacs
Baska
Work from Office
Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation. To ensure that product is produced and stored according to the appropriate documentation in order to obtain the desired quality. Responsible for Review comments of MF, FMEA, RA protocol (Sampling plan, Process validation protocol) and compliance. Handling Support of Trouble shooting batches for data comparison and route cause Investigation at...
Posted 3 months ago
15 - 20 years
75 - 80 Lacs
Baska, Halol
Work from Office
QA will lead and oversee the entire QA function manufacturing facility,includes both General Injectable and General OSD units. ensuring compliance, USFDA, ensuring compliance to cGMP, cross-functional collaboration quality-driven site operations. Required Candidate profile Site Quality Leadership, Compliance Management, (QMS) Ownership, Cross-functional Collaboration, Batch Release and Product Quality Oversight, Training and Development, Qualifications & Validations
Posted 4 months ago
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