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required and ensure the timely updating of quality system documentationtimely reports to qa lab supervisor any abnormal issues to ensure timely resolutionsmunicate with related department for shift issue (equipment, environment, sample etc.,) that has impact to testing timely.responsible for performing internal audits especially in regard to areas that are microbiological sensitiveresponsible for training staff in regard to microbial issues and gmp, 5s, sops, etc.manage all resources associated with the pletion of microbiological activities to agreed schedules and highlight and make proposals to management where resources do not match requirements.ensure continued professional development to maintain current knowledge on microbiological requirements for medical devices and aqueous productsinput into rb best practice forums regarding microbiological activities and implement best practice from other rb sites.must perform environmental duties such as segregation of waste and following gmps (good manufacturing practices) in order to ply with iso 14001.must ply with pany health and safety procedures and policies and must immediately report any unsafe condition to ensure a safe workplace.must ply with pany health and safety procedures and policies and must immediately report any unsafe conditions understand and ply with pany environmental and health and safety policies, and procedures. understands site objectives.any other duties mensurate with the level and scope根據(jù)作業(yè)指導(dǎo)書按時(shí)完成相關(guān)微生物檢驗(yàn):水,產(chǎn)品和工廠環(huán)境,以確保產(chǎn)品符合法規(guī)和公司標(biāo)準(zhǔn)。負(fù)責(zé)標(biāo)識(shí)測(cè)試產(chǎn)品的檢驗(yàn)狀態(tài),隔離任何不符合微生物標(biāo)準(zhǔn)的產(chǎn)品,防止不合格產(chǎn)品被使用。根據(jù)作業(yè)指導(dǎo)書正確使用校準(zhǔn)設(shè)備及時(shí)測(cè)試進(jìn)貨原材料,包材,過(guò)程材料,qa放行檢驗(yàn)日常檢驗(yàn)及特殊實(shí)驗(yàn),以確保產(chǎn)品質(zhì)量符合公司的標(biāo)準(zhǔn)。,確保符合公司作業(yè)指導(dǎo)書。amp。最終決定在sap中放行或凍結(jié)批次。調(diào)查檢驗(yàn)結(jié)果超標(biāo)是否與樣品,設(shè)備,人員,方法等方面有關(guān),如果發(fā)現(xiàn)檢驗(yàn)結(jié)果超標(biāo)與實(shí)驗(yàn)室有關(guān),則需要快速采取措施。,維護(hù)實(shí)驗(yàn)室日志和記錄,以確保可追溯性。,確保及時(shí)更新質(zhì)量體系中的相關(guān)文件。,確保及時(shí)將問題解決。 (設(shè)備,環(huán)境,樣品等)。,