BaseCon has ambitions: We are looking for a CSV manager/QA
Oferta de trabajo de Analistas de sistemas en HOVEDSTADEN (Dinamarca)
Clasificación del trabajo:Profesionales científicos e intelectuales : Profesionales de tecnología de la información y las comunicaciones : Desarrolladores y analistas de software y multimedios : Analistas de sistemas. Arbejde, der forudsætter viden på højeste niveau inden for pågældende område : Arbejde inden for informations- og kommunikationsteknologi : Udvikling og analyse af software og applikationer : Systemanalytikerarbejde.
Descripción de la oferta de trabajo:
Job description BaseCon offers a modern and efficient software for the clinical safety and pharmacovigilance domain. Our drug safety software has been in the market for the past 18 years. We constantly work together to improve and enhance our software. We are looking for a highly motivated individual to start with immediate effect. It is important you are a team player with a personnel insight and confidence. We aim on keeping the deadlines with a focus on quality of the deliverables. It would be a big advantage if you are used to working with a large degree of documentation, which is an important prerequisite for keeping our very high-quality standard. You can manage and create full Validation Package for Pharmacovigilance IT system releases. I.e. create Requirements Specification, Validation Plan, Operational Qualification Plan and Report etc. Create test scripts. •Manage company MVP. •Manage and maintain the company QMS (manual system). •Manage deviations. •Stay updated on global pharmacovigilance regulations, directives and standards. •Chair audits. •Capture, maintain and manage CAPAs. •Conduct supplier audit. You will need to be experienced in working with computer systems validation management, Experience in GAMP 5, CFR 21 part 11, pharmacovigilance legislation. Eudravigilance. Several years of experience in GxP, especially GDP and GVP. •Experienced in Pharmacovigilance. •Knowledge in QMS. •Ability to multi-task. •Analytic, problem solving approach. •Computer competency in Word, Excel, Power Point. •Knowledge about database structures. •Audit/inspection experience. Carreer possibilities You will have good QA opportunities within the company both professionally and position-wise. We regularly send the QA team on courses to update their knowledge and we can constantly offer new tasks and projects. We are very customer-oriented, so there will be good opportunities for rewarding dialogues with customers on development requirements and migration projects. You get a very versatile QA work. Company BaseCon is a privately-owned company founded in 1999. We have since that been developing a so- called “Drug Safety Database” with which it is possible to register, make stats and reporting of Adverse Events in Medicinal Products. It is a requirement from the national authorities around the world that the Pharmacetutical Companies keep surveillance and report statistics on Adverse Events to the authorities. Our software supports these tasks and secures that our customer can comply with these requirements/regulations. BaseCon has a strong brand in Europe and our customer base is growing. About 90% of our customers are located outside Denmark. Our goal is to be in the top 3 of vendors before 2020. We have a strong product in a growing market. The working place We are working Agile with a relatively flat organizational structure, but a large degree of self- responsibility and flexible hours and the opportunity to work from home. We offer an informal environment with high level of daily interaction between the development team and with our other employees. It is easy to get to our office in Hedehusene by car and by public transport. We work with Jira project management tool. Practicalities Right now it's not a full time job Salary: individual Start: a.s.a.p. Application deadline: 15/8-2017 Contact Send your application to Sven Kjær Nielsen, sknbasecon.com if you want a job in a company with ambitions. If you have any questions, you are also welcome to call 4697 6680. We look forward to reading your application and welcoming you for an interview.
Servicio de empleo de origen:AMS, Servicios Públicos de Empleo, Dinamarca.