Beschreibung
Technical Writer - German & English
Edelway is a Swiss Professional Services Consultancy. One of our best clients, a global pharmaceutical company based in the Bern/Basel area, is currently looking for a Senior Technical Writer with ideally experience in CAPA (Corrective and Preventive Actions) and NCR (Nomenclature Change Request) to join them on a long term basis.
Required languages: German AND English.
THE ROLE
*With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.)
*Support to generate the new Standard for process in EU
*Consultancy and guidance of all employees and Manager regarding CAPA and NCR requirements (external and internal)
*Generate Redline as per instructions
*Generate SOP (Standard Operating Procedures) in accordance to the regulation
*With oversight from the Core Team Leads (CTL), generate reports, graphical analyses, and trend charting
*Perform database analyses as directed by CTL (Pareto, trend charting, histogram, etc.)
YOUR PROFILE
*Minimum of 4 years experience as document writer or similar position.
*Ideally experience with CAPA and NCR
*Proficiency with a variety of computer software applications in word processing, Spreadsheets, database and presentation (MS Word, Excel, PowerPoint, etc.)
*Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.)
*Compliance experience in the medical devices is a plus
*Familiarity and interaction experience with regulatory auditing bodies preferred
*Documented training in FDA QSR, ISO required
If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.