12 Jobs in Baska

For Production (Injectable): Exposure pertaining to Groninger vial filling, Groninger Bottle fiiling, Fedegari Autoclave, NKP vial Filling machine, lyophilizer, Spray dryer, Aseptic process, complex manufacturing, Exposure to CIP/ SIP, SKID manufacturing, pre-fill syringe, QMS is required For Production (OSD): Exposure of granulation, compression and coating process, BMR, Change control, CAPA, For Engineering: Exposure of maintenance of Sterile Manufacturing Plant, maintenance of Autoclave, Filling machine - Vial, Ampoule, Ophthalmic, Lyophilizer, Freeze dryer machine, BFS machine is required Job Location: Sun Pharmaceutical Medicare Limited (Baska) : Nr. Hotel Sarvottam, Survey NO 22 & 24 ,...

Owning of Aseptic process simulation program of the site including protocol / operators and intervention qualification program / Trending and Aseptic process simulation summary report. Own and continually develop the Site s Contamination Control Strategy. Ensure Contamination control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Lead Sterility Assurance committee for the site . Review and approval of Microbiological environmental monitoring program, identify trends and implement effective risk mitigation Guide the investigation of contamination related non-conformance and events and provide technical input for microbiological me...

Job Title: Executive/Senior Executive, Operational Excellence Job Grade: G11B/G12A Department Operation Excellence Location: Baska Areas of Responsibility OEE Tracking and improvement of all areas including bottlenecks Change over time tracking and reduction for all areas including bottlenecks using SMED. Batch cycle time improvement for concerned products. Yield improvement on the basis of high value and high-volume products. Idea generation, Implementation, Saving tracking every month. Facilitation of performance dialogues in all area. Site performance dashboards updation on monthly basis. Successfully delivered all operation excellence training. Facilitation and conducting all Quality Cir...

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

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...

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.

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...

Computer System Validation, QMS and IT

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...

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...

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...

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