8 Jobs in Baska

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 velocity, non-viable particle count, air flow pattern as per define schedule, review of calibration certificate for measuring devices]. Ensure and updation of periodic performance verification, calibration, Bulk SIP and smoke study schedule as per available data. Review of all AHU PAO test and NVPC report form for periodic verification, Filter Replacement intimation form, Equipment/instrument inward & Deletion intimation slip & all equipments print reports during qualification. Preparation of master document for periodic performance verification of EFU system Preparation & review of SOPs through EDMS Software Execution of FAT and SAT of equipment, facility and utilities as per requirement. Equipment Periodic performance verification schedule preparation, review, updation and provide data required for monthly report preparation. QE related Instrument calibration schedule preparation (Ellab wireless system, Ellab wired system, Rotronic data loggers certificate review and updation as per available data

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 initiatives Preferred candidate profile Basic knowledge of sterile/aseptic manufacturing / pharma production equipment Interest in plant maintenance Willingness to work in shifts & controlled environment Good documentation and communication skills Attention to detail and compliance mindset Good observations and analytical skiils

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 , Post :Baska , Tal: Halol : 389350 Dist. Panchmahal, Gujarat, INDIA. Mb No : 02676 610 603 / 628

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 Sun/CMO. Investigation for product trouble shooting To ensure that the Packing operations or activities are carried out on timely. To monitor prior checkup of equipment planned for usage in Scale up, Exhibit, Process validation batches ie Equipment preparation, vial washing dehydrogenation, CIP/SIP System, PLCs, instruments etc Responsible for Supervise and perform skid trials for better product development and process improvements and also minimizing manufacturing related constraints in future. To prepare the Scale up report, get evaluated and signed by authorized person prior going to Exhibit batches their submitted to QA. Responsible to help the officers and operators to standardize production activities to achieve better efficiency and quality. To review validation protocol, SOP and other cGMP Documents. Close coordination with all the supporting departments ie Production, NPQC, QA, QE (Engineering) and warehouse for smooth running of Scale up, Exhibit, Process validation batches. To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR.

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 Sun/CMO. Investigation for product trouble shooting To ensure that the Packing operations or activities are carried out on timely. To monitor prior checkup of equipment planned for usage in Scale up, Exhibit, Process validation batches ie Equipment preparation, vial washing dehydrogenation, CIP/SIP System, PLCs, instruments etc Responsible for Supervise and perform skid trials for better product development and process improvements and also minimizing manufacturing related constraints in future. To prepare the Scale up report, get evaluated and signed by authorized person prior going to Exhibit batches their submitted to QA. Responsible to help the officers and operators to standardize production activities to achieve better efficiency and quality. To review validation protocol, SOP and other cGMP Documents. Close coordination with all the supporting departments ie Production, NPQC, QA, QE (Engineering) and warehouse for smooth running of Scale up, Exhibit, Process validation batches. To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR.

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