One of the major pharmaceutical companies in Europe has 2 brand new openings for CSV – IT Quality consultants to join their team in Barcelona, Spain. The positions are 6-month contract with possible extension and some travel will be required to Germany, Switzerland and USA. As well as offering strong Computer Systems Validation (CSV) experience from a Pharma environment, you must be able to have excellent oral and written skills in English. Excellent rates of pay.
Based near Barcelona, this role will suit an experienced CSV professional with knowledge of quality management and CSV duties on IT projects and programs. You will be conducting quality reviews of IT systems and processes, writing, reviewing and approving required documentation and ensuring compliance with regulations, standards and client’s QMS system. The role involves reviewing technical writing, supporting Power Point presentation also writing, reviewing and implementing IT procedures, processes and working instructions. You must have excellent attention to detail to be able to identify errors or deficiencies in IT systems and processes and drive their continuous improvement. Risk assessments and risk mitigations will be an important part of the role and to support testing, documentation and change management activities. You will be reporting to the IT Quality Business Manager.
With at least 5 years’ hands-on experience in computer system validation and quality management from the pharmaceutical industry (or perhaps in quality assurance from the healthcare industry), you will be highly skilled in the following:
- CSV activities on GxP classified IT projects/systems
- Good Knowledge of 21 CFR Part 11 and GAMP5
- Good Knowledge of Microsoft Office tools (Word, PowerPoint, Share Point, Excel, Visio, Project)
- Experiences working on IT/SAP projects and programs within multicultural, global or virtual project teams in a matrix environment
- Ideally you would have experience in Windchill, change management tools and HP ALM
- Strong business communication and presentation skills in English
This position will suit someone who is adaptable to changes and enjoys working in a team environment.
If you can be available at short notice to commence a contract near Barcelona please get in touch with Adrienn Prezenszki at Next Phase ASAP. Full details will be provided on application.
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