Lab QA

To review Raw Material, PackagingMaterial, In-process, Finished product, shelf life specification and itsrelevant Method of analysis and authorize the Testing work sheet. To review andapproved analytical data of Raw material, Packaging material, In-process,Finished product, Stability study and Consumable materials in LIMS. To ensure the compliance and routinechecks of current Good Laboratory Practices in the Quality Control department. Toreview chemical and microbiological analytical method validation, methodtransfer and Verification protocol and report. Handling, storage, withdrawal andreconciliation of stability samples in LIMS or out of LIMS. To reviewanalytical data and trend summary reports of stability studies. To verify theoutside laboratory samples and its reports. To ensure and review Change control,Deviation, LIR, OOS, OOT, OOC, CAPA, Trends and other investigations of qualitycontrol and quality assurance department. To initiate the departmental changecontrol, deviation, CAPA, BDIF and investigation report. To review thequalification and calibration documents of QC instruments/equipments. Toreview stability protocol and approved the schedule related to quality controldepartment. To prepare and review, stabilityschedule, other study protocol and their reports as per requirements. Toprepare and review the qualification/validation documents related to qualityassurance. To review the audit trial of the QCinstrument or equipment, Stability chambers/incubators. Temperature andhumidity data recording, review and approved for stability chambers/incubatorsand respective rooms. To participate in regulatory audit andits compliance. Notify event of QMS to customer andcompliance team, response to their query/comments. Handling and trending ofOversight observation and its compliance. To provide the Quality index andQuality Management review data. To ensure calibration, Qualification andPreventive maintenance of incubators and chambers as per schedule. To ensureand review the Alarm logs, alarm acknowledgement, alarm trending and alarmassessment. To review Critical Quality Attributes trend data. To review the protocol, analytical dataand report for in vitro Bioequivalence studies. To receive, store, control,reconcile, retain and destroy Investigational products for in vitroBioequivalence studies. Review and approved the data in LIMS (LaboratoryInformation Management System). Requirements: Qualification : B.Sc./M.Sc./B.Pharm/M.Pharm Experience / Exposure in (2 points) : Must have knowledge and experience in injectable plant.