Kuwait City, Al Asimah, Kuwait
> Sample management and sample segregation and related analysis. > Autoclave operation and Qualification. > Microbial Isolate identification and maintenance and management. > Media management/ preparation and sterilization, labelling,pre incubation, performing growth promotion test, storage and reconciliation. > Biological indicator suitability test and biological indicator recovery study. > Initiation and investigation of out of specifications/ out of trend results, change control, deviation and incidents. >Trend preparation and documentation. Audits - Facing audits and compliance to the observation . Performing the ENM analysis QC and updating the results in Utility LIMS, LABWARE. > Environmental monitoring for the area Fill finish facility and document the same. > Qualification and re- qualification for Fill finish facility. Assessing production ,QA , external vendors ,auditors, and other personnel for gowning qualification /re-qualification and documentation the same. > Aseptic process simulation. > Container closure integrity test. > Line clearance for filling and sealing and documenting the same. Giving filling line clearance for formulation, vial combiline, cartridge combiline, syringe filling areas.