Imfundo, UkuQeqesha, iMbuyekezo kunye neNinzi
Kwimveliso elawulwa kakhulu njengemvavanyo yecilisi, inxaxheba ekuqinisekiseni ikhwalithi ibaluleke kakhulu ekuqokeleleni nasekunikeleni ingxelo yolwazi oluchanileyo ngelixa lihlala lihambelana nemisebenzi yenkampani, iimfuno zomgaqo-nkqubo kunye nemithetho yomthetho.
Umphathi wokuqinisekisa umgangatho wendawo yokuphanda ngeklinikhi ngumntu oyintloko kwinkampani echaphazelekayo ngokugcina ukuchaneka ngokuphelisa inkunkuma.
Le nxaxheba ixanduva lokuchonga iingxaki ngaphambi kokuba zenzeke; nazo zonke iinjongo, kukho imingeni kunye nobungozi obunokwenzeka kwaye i-QA kufuneka ikwazi ukukunceda ukuchonga imiba phambi kwexesha ukuqinisekisa ukuba abasebenzi balungiselelwe.
Ngokutsho kwe-Payscale.com, uluhlu lomvuzo lomphathi wokuqinisekisa umgangatho ububanzi, ukusuka kwi-$ 42,381- $ 112,054. Lewebhusayithi ikwazisa ukuba lo msebenzi ulinganiswe kumsebenzi onolwazi, kunye nangaphezulu kwesiqingatha se-Quality assurance (QA) abasebenzi baseUnited States ababika ngaphezu kweminyaka eyi-10 yamava.
Iveki yomSebenzi yokuSebenza
Abasebenzi abaninzi be-QA kuphando lwezonyango basebenza iiyure ezisibhozo ngosuku, iiyure ezingama-40 ngeveki, kodwa umsebenzi ufuna ukuguquguquka kwaye oku kungadinga iiyure ezongezelelweyo. Imisebenzi iyahlukahluka imihla ngemihla kuxhomekeke kuphicotho-zincwadi ezicwangcisiweyo, imingeni, njl.
Ngokubanzi, i-QA inoxanduva loku:
- Imigaqo yokubhala.
- Ukubonelela ngokuhlaziywa kwimiqathango yokulawula kwishishini.
- Ukuseka iinkqubo nokubeka esweni ingxelo kunye nokuphuculwa okunokwenzeka.
- Ukubeka esweni abasebenzi ngokuthotyelwa kwemigaqo-nkqubo yenkampani, imimiselo yoshishino kunye neemfuno ezixhasayo.
- Ukubhala iziCwangciso zokuCwangcisa nokuCwangcisa (CAPA).
- Xa i-QA ibona umntu ngokuthobela, umsebenzi wabo ukubakhokela ekuthotyelweni-ukunika iingcebiso malunga nendlela yokuthobela ngakumbi. Ngamanye amaxesha kuthetha ukuthatha iinkqubo zeenkampani, ukuhlaziya, ukucacisa kunye / okanye ukulungiswa kweenkqubo zethu. Amanye amaxesha athetha ukucinga ngaphandle kwebhokisi ukufumana isisombululo esitsha esingazange sicingisise malunga nesifundo.
I-QA isebenzisa ixesha layo lihlaziya iirekhodi zokufunda kunye neenkqubo zeenkampani zokutyelela iikliniki.
Imfundo noQeqesho
Unokufumana ubungqinisisi njengengcali ye-QA, kodwa akuyimfuneko. Kukho neenkqubo zokuqeqesha ezinikezelwa iikholeji, iiyunivesithi kunye neenkqubo zesatifikethi. Ngamanye amaxesha uqeqesho olufanelekileyo lulo msebenzi.
Ukuze uphumelele, umphathi wokuqinisekisa umgangatho kufuneka abe nolwazi kakuhle kwiinkqubo ezifanelekileyo zeklinikhi kunye nemigaqo ye-FDA kunye neqela labanye abantu abanolwazi njengemithombo. Kwakhona kunyanzelekile ukuphuhlisa izakhono zabantu eziza kukunceda ufumane ukuzithemba nokuhlonipha xa uxhulumana nabasebenzi. Kwimeko ethile kuthi-ukuqinisekiswa komgangatho - bahlalutya abanye umsebenzi wabantu ukubanceda baphuculwe ngokufanelekileyo, ngoko ukuqonda indlela yokuseka ubudlelwane bobugcisa kuyimfuneko emsebenzini.
Kwakhona kubalulekile ukuba ukwazi ukugcina ingqondo evulekile kuba kukho rhoqo isisombululo esinye kwisingxaki. Ngamanye amaxesha abantu banokuvakalelwa ngathi kunendlela enye yokuthobela imigaqo nemigaqo. Ukuba asinayo ingqondo evulekile, kukho ithuba lokuba singaphuthelwa ngamathuba okuphucula nokukhula. Ngexesha elifanayo, umphathi wokuqinisekisa umgangatho mazazi ukuba kufuneka eme nini ngokunyanzela ukunyanzelisa umgaqo othile.
Iintlobo zeeNkampani zoPhando lweeKlinikhi eziSebenza ngabasebenzi be-QA
Ukuba isibonelelo sophando lwekliniki sinomnyango we-QA, oko kukuphawu lwesayithi elivuthiweyo. Ngokuqhelekileyo, amasayithi ophando awaqalanga kwisebe le-QA kodwa ekugqibeleni ayaqonda ukuxhamla isebe elizinikezele ukuphucula iinkqubo nokubonelela ngongamele uqeqesho kunye nokuthotyelwa. Ukuba neSebe le-QA libonisa ukuba inkampani iyazinikezela ekukhuleni ngokweenkqubo kunye nokuphucula umgangatho wophando lwezifundo.
IiNkonzo ze-QA zinkulu kwiinjongo zokuthengisa kuba abaxhasi baqonda ixabiso kwiziko elivuthiweyo.
Isetyenzisi seSakhono
Kubalulekile ukuba ube nolwazi oluthe ngqo, ulwazi malunga nomgaqo-nkqubo, iinkqubo zokusebenza eziqhelekileyo (SOPs) kunye nemigaqo-nkqubo yewebhusayithi. Kumele ube nokulandela ngokufanelekileyo, ubuchule obuhle bekhompyutheni, amava adlulileyo, izakhono zonxibelelwano ezintle (ngomlomo nangobhaliweyo), ujonge ukusebenzisana nabanye abantu kunye nokuxazulula iingxaki ngexesha uthabatha imingeni emitsha. Kwakhona, kubalulekile ukuqhubeka nokukhula kobuqu kunye nobugcisa.
Umkhondo Wengqesho
Ngokuqhelekileyo, uba ngu-QA umphicothi-zincwadi / oyingcali xa uqala ukhondo lomsebenzi kwisayithi yophando. Ukusuka apho, ungaya kwindima yokulawula apho ulawula abanye abaphicothi-zincwadi. Emva kokuba uqonde kwiMigangatho yeCandelo leNgcaciso ye-Clinical kunye ne-FDA imigaqo kunye namava ekuqhubeni nasekulawuleni uphicotho-zincwadi luvulela umnyango ithuba kunye nokukhula. Ngokuxhomekeka kubukhulu benkampani yakho, unokuba ne-QA Directors (ebizwa ngokuba yi-Global QA) ejongene nabanye abaphathi be-QA kwiindawo ezininzi zophando. Unokwazi ukhethe indlela eyahlukileyo ngokunikezela ngeenkonzo ze-QA kwiindawo zophando kunye nabaxhasayo, okanye ngokujoyina iqela elikhethekileyo leQA. Oku kuthintela kuphela umgangatho wamathuba ootitshala be-QA.