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Quality Assurance Manager

4 months ago

Stellenbosch, South Africa Stellenbosch University Full time

Duties/Pligte
- Verskaf ondersteuning en opleiding in die bevordering en assessering van voldoening aan Goeie Kliniese Praktyk (GCP) regulasies, riglyne en bedryfsprosedures;
- Ontwikkel, bestuur en implementer 'n gehalteversekeringsplan;
- Ontwikkel, versprei, bestuur en koördineer opleiding oor Standard Bedryfsprosedures soos vereis binne die eenheid, insluitend DAIDS SOP's;
- Hulpverlening met al die voorbereidings van alle eksterne monitering en oudits (verskaf ondersteuning tydens en na oudits);
- Moniteer alle deurlopende kliniese proewe gedurende hul duur binne die Eenheid, wat wel kliniese terreinmoniteringsbesoeke op 'n gereelde basis behels soos vereis (interne monitering);
- Moniteer die voorleggings van eksterne veiligheidsverslae per studie;
- Identifiseer tekortkominge en ontwikkel en hou toesig ooren oor die implementering van regstellende aksieplanne soos vereis;
- Verskaf deurlopende opleiding aan personeel oor veiligheidsmonitering en verslagdoeningsvereistes, hantering van biologiese monsters en databestuursaktiwiteite;
- Verseker dat regulatoriese dokumente op datum bly, bv., HSP, GCP, HPCSA, SAPC en SANC;
- Hou lab dokumente op datum, insluitend Tegniese Protokol, SANAS, CV's, IATA en Verwysingsreekse.
- Providing support and training in the promotion and assessment of compliance with Good Clinical Practice (GCP) regulations, guidelines, and

operating procedures;
- Developing, managing and implementing a Quality Assurance Plan;
- Developing, distributing, managing and coordinating training on Standard Operating Procedures as required within the Unit, including DAIDS SOP's;
- Assisting with all the preparations of all external monitoring and audits (providing support during and after audits);
- Monitoring all ongoing clinical trials throughout their duration within the Unit, which involves clinical site monitoring visits on a regular basis as required (internal monitoring);
- Monitoring the submissions of external safety reports per study;
- Identifying deficiencies and developing and overseeing implementation of corrective action plans as required;
- Providing ongoing training to study staff on safety monitoring and reporting requirements, handling of biological specimens and data management activities;
- Ensuring that regulatory documents are up to date, e.g., HSP, GCP, HPCSA, SAPC and SANC;
- Keeping lab documents updated, including Technical Protocol, SANAS, CV's, IATA, and Reference Ranges.

Job Requirements/Pos Vereistes
- Toepaslike wetenskaplike / mediese / verpleging-graad;
- Vyf jaar se navorsings ervaring binne 'n kliniese navorsingsomgewing is noodsaaklik;
- Drie jaar gehalteversekering-ervaring binne 'n kliniese navorsings omgewing;
- Drie jaar bestuurservaring binne 'n kliniese navorsingsomgewing;
- Goeie kliniese praktyk-oudit ervaring, insluitend kliniese monitering/kliniese proewebestuur en terreinbestuur;
- Die vermoë om aan probleme van matige tot diverse omvang te kan werk en om goeie oordeel uit te oefen binne gedefinieerde prosedures en beleide om toepaslike optrede te bepaal;
- In staat en bereidwillig om as adviseur op te tree en 'n aktiewe rol te aanvaar soos vereis om doelwitte te bereik of probleme op te los;
- Bly op hoogte met kennis van kliniese proefmetodologie, GCP, ICH, en ander plaaslike/internasionale regulatoriese riglyne en vereistes, deur bywoning van opleidingskursusse, literatuuroorsigte, ens.
- Relevant scientific / medical / nursing degree;
- Five years' research experience within a clinical research environment is essential;
- Three years' quality assurance experience within a clinical research environment;
- Three years' management experience within a clinical research environment;
- Good Clinical Practice auditing experience, including clinical monitoring/clinical trials management and site management;
- The ability to work on problems of moderate to diverse scope and to exercise good judgment within defined procedures and policies to determine appropriate action;
- Able and willing to act as advisor and assume an active role as required to meet goals or resolve problems;
- Remaining current in knowledge of clinical trial methodology, GCP, ICH, and other local/international regulatory guidelines and requirements, through attendance at training courses, literature reviews, etc.

Recommendation/Aanbeveling
- Geregistreerde lidmaatskap by die Suid-Afrikaanse Verpleegings Raad (SANC);
- A goeie begrip van twee van Suid-Afrika se elf amptelike tale;
- Eie betroubare voertuig;
- 'n Geldige rybewys;
- Bereidwilligheid en beskikbaarheid om na ure te werk.
- Registered membership with the South African Nursing Council (SANC);
- A good command of two of South Africa's 11 official languages;
- Own reliable transport;
- A valid driver's licence;
- Willingness and availability to work after hours.