You are experienced in the field of GxP & would you like to contribute your expertise in an agile environment? In this position you will be responsible for audits in the GCP field & support the quality of WÖRWAG Pharma's products. Look forward to a flexible & familiar environment with high development opportunities & benefit from an exceptionally broad range of tasks. Profit from an attractive salaray, flexible working hours & the possibility of working from home in a future proof family run company.
22 international offices in Asia, Europe & South AmericaAnnual sales (2020) of €235.8 millionFamily-runInternational diversity (also at headquarters) with regional roots Design opportunitiesGrowthThe courage to try new thingsDynamic & yet reliable
Numerous additional remunerationse.g.Mobile working Company pension planJob-ticket for public transport Attractive models of salary conversionPaternity leaveMeal allowanceAid for birth / wedding / anniversariesMedical officerDealer discountsAssistance in finding accommodationHealth DaysWide range of offers for personal & professional developmentDirect insurance allowanceFlexible trust-based working hoursDiscounts on over-the-counter (OTC) pharmacy itemsSupporting offers for your general well-beingorFor the compatibility of family & career
This is your team:
10-15 direct colleagues
Diverse / From young to old
Flat hierarchiesReporting to> Team lead
These are your responsibilities:
Successful participation in the Global Clinical Research (G_MA_CR) & Global Pharmacovigilance (G_MA_PV) departmentsFirst contact for audits in the GCP area
Implementation of internal & external auditsAs part of the risk-based audit program for the G_MA_CR & G_MA_PV areaProvide GxP compliant advice & guidance to Global Clinical Research teams:External study execution (e.g. hospitals, clinical research organizations)Provide GxP compliant advice & guidance to Global Pharmacovigilance teams:Internal consulting at the sitesParticipation in risk assessments for clinical trialsas well asDerivation of suitable measuresSupport for development, improvement & trainingofGxP relevant processes & specification documents for the Global Clinical Research & Global Pharmacovigilance teamResponsibility of planning, tracking & effectiveness control of corrective & preventive actions (CAPA)andCoordination of deviationsIn addition:Contribute to the creation of global & local process descriptions(including global & national SOPs as well as work instructions)
ColleaguesEmployees of other teamsOne / few superiorsGlobal Quality UnitInterface with:Global Clinical ResearchGlobal PharmacovigilanceClinical studiesExternalsSuppliers & service providers
Required:Knowledge in the use of relevant pharmaceutical IT systems (DocuBridge, Amplexor, Trackwise)User knowledge with MS OfficeConfident & professional communication skillsKnowledge of the relevant regulations in the field of GCP
TeamworkSelf-confidenceHigh willingness to learnCommunication skillsFlexibilityAssertivenessNegotiation skills
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