Imfundo, Ukuqeqesha, Isihlomelo nokuningi
Embonini elawulwa kakhulu efana nokuhlolwa kocwaningo lwezokwelapha, indima yokuqinisekiswa kwekhwalithi ibaluleke kakhulu ekuqoqeni nasekubikeni idatha yokutadisha okunembile ngenkathi ihlala ihambisana nemikhuba yenkampani, izidingo zomthethosisekelo, kanye nemigomo yenhlangano.
Imenenja yokuqinisekisa ikhwalithi yesayithi lokucwaninga emtholampilo ngumuntu oyinhloko enkampanini ethintekayo ekulondolozeni ukusebenza kahle ngokuqeda imfucuza.
Le ndima ibhekene nokuhlonza izinkinga ngaphambi kokuba kwenzeke; nazo zonke izifundo, kunezinselelo kanye nezingozi ezingenzeka futhi i-QA idinga ukusiza ukukhomba izinkinga ngaphambi kwesikhathi ukuqinisekisa ukuthi abasebenzi balungile.
Ngokusho kwe-Payscale.com, uhla lwamholo lomphathi wokuqinisekisa ikhwalithi lubanzi, kusuka ku-$ 42,381- $ 112,054. Lewebhusayithi iphinde ibike ukuthi lo msebenzi ulinganiswe nesisebenzi esinolwazi, futhi ngaphezu kwengxenye yesisebenzi se-quality assurance (QA) e-United States ebika iminyaka engaphezu kwengu-10 yobufakazi.
Iviki lomsebenzi elijwayelekile
Abasebenzi abaningi base-QA ocwaningweni lwezokwelapha basebenza amahora ayisishiyagalombili ngosuku, amahora angu-40 ngesonto, kodwa umsebenzi udinga ukuguquguquka futhi lokhu kungadinga amahora engeziwe. Imisebenzi iyahlukahluka nosuku ngokuya ngokucwaninga okuhleliwe, izinselelo, njll.
Ngokubanzi, i-QA inesibopho se:
- Izinqubomgomo zokubhala.
- Ukuhlinzeka ngezibuyekezo ezinkambisweni zokulawula embonini.
- Ukusungula izinqubo nokuqapha impendulo kanye nokuthuthukiswa okunokwenzeka.
- Ukuqapha abasebenzi ngokuhambisana nezinqubomgomo zenkampani, imithethonqubo yezimboni kanye nezidingo ezixhasayo.
- Ukubhala izinhlelo zokulungisa nokuzivikela (CAPA).
- Uma i-QA ibona umuntu engalaleli, umsebenzi wabo ukubaqondisa emuva ekuhambisaneni - ubanikeza iziphakamiso mayelana nendlela yokuthobela ngokwengeziwe. Ngezinye izikhathi lokho kusho ukuhamba ngezinqubomgomo zezinkampani, ukuhlaziya, ukucacisa kanye / noma ukulungisa kahle izinqubo zethu. Okunye izikhathi okusho ukucabanga ngaphandle kwebhokisi ukuthola isisombululo esisha esingakaze sicatshangelwe ngesifundo.
I-QA isebenzisa isikhathi esiningi sokubuyekeza amarekhodi okucwaninga nezinqubo zenkampani yokuvakashelwa emitholampilo.
Imfundo Nokuqeqesha
Ungathola isitifiketi njengochwepheshe we-QA, kodwa akudingekile. Kunezinhlelo zokuqeqesha ezihlinzekwa ngamakholeji, amanyuvesi kanye nezinhlelo zesitifiketi. Ngezinye izikhathi ukuqeqeshwa okungcono kunomsebenzi.
Ukuze uphumelele, imenenja yesiqiniseko sekhwalithi kufanele ikwazi kahle imikhuba emihle yokwelapha kanye nemithetho ye-FDA futhi ibe neqembu labanye abantu abanolwazi njengemithombo. Kubalulekile futhi ukuthuthukisa amakhono abantu azokusiza ukuba uthembeke futhi uhloniphe lapho uxhumana nabasebenza nabo. Kwezinye izici thina - ukuqinisekiswa kwekhwalithi - bahlaziya umsebenzi wabanye abantu ukuze babasize bathuthuke ngokuzikhandla, ngakho-ke ukuqonda indlela yokwakha ubuhlobo obuhle kuyadingeka emsebenzini.
Kubalulekile futhi ukwazi ukugcina ingqondo evulekile ngoba kunesisombululo esiningi kunenkinga eyodwa yenkinga. Ngezinye izikhathi abantu bangase bazizwe sengathi kunendlela eyodwa kuphela yokuhambisana nemigomo nemigomo. Uma singenayo ingqondo evulekile, kunethuba elihle lokuthi singaphuthelwa ngamathuba okuthuthukisa nokukhula. Ngesikhathi esifanayo, umphathi wokuqinisekisa ikhwalithi kufanele azi ukuthi ukuma uqine ukuphoqelela inqubomgomo ethile.
Izinhlobo zezinkampani zocwaningo lwezokwelapha ezisebenzisa i-QA Personnel
Uma indawo yokucwaninga emtholampilo inomnyango we-QA, lokho kuyisibonakaliso sesayithi elivuthiwe. Ngokuvamile, izindawo zokucwaninga aziqali ngomnyango we-QA kodwa ekugcineni zibona inzuzo yokubamba umnyango ozinikezele ukuthuthukisa izinqubo nokuhlinzeka ukuhlolwa kokuqeqeshwa nokuhambisana. Ukuba nomnyango we-QA kubonisa nokuthi inkampani inikezelwe ekukhuleni ngokuzikhandla ngezinqubo ezihlelekile nokuthuthukisa ikhwalithi yezifundo zocwaningo.
Iminyango ye-QA inhle kakhulu ngezinhloso zokuthengisa ngoba abaxhasi baqonda ukubaluleka kusayithi elivuthiwe.
Isethi Yokusebenza
Kubalulekile ukuba kube nemininingwane eqondisiwe, ulwazi mayelana nomthethonqubo, izinqubo zokusebenza ezijwayelekile (i-SOPs) nezinqubomgomo zesayithi. Kumelwe futhi ube nokulandela okuhle, amakhono amakhompiyutha amahle, isipiliyoni sangaphambilini, amakhono amahle kakhulu okuxhumana (ngomlomo nangobhalisiwe), ujabulele ukusebenza nabanye abantu kanye nokuxazulula izinkinga ngenkathi uthatha izinselele ezintsha. Futhi, kubalulekile ukuqhubeka nokukhula komuntu siqu nochwepheshe.
I-Track Career Potential
Ngokuvamile, uba ngu-QA auditor / ochwepheshe uma uqala ithrekhi yakho yomsebenzi endaweni yokucwaninga. Ukusuka lapho, ungangena indima yokuphatha lapho uphatha khona abanye abacwaningi. Uma usubambelele emithethweni ye-Good Clinical Practices kanye ne-FDA kanye nokuhlangenwe nakho ekuqhubeni nasekulawuleni ukuhlolwa kwamabhuku kuvulela umnyango amathuba nokukhula. Ngokuya ngobukhulu benkampani yakho, ungaba ne-QA Directors (ebizwa nangokuthi i-Global QA) eqondisa abanye abaphathi be-QA ezindaweni eziningi zocwaningo. Ungakhetha ngisho indlela ehlukile ngokunikeza amasevisi okubonisana ne-QA kumasayithi ocwaningo nabaxhasi, noma ngokujoyina iqembu elikhethekile le-QA le-sponsor. Lokhu kuthinta kuphela amathuba okuba abasebenzi be-QA.