Medical Documentarist as Assistant Quality Assurance (m/f)
The goal of Vakzine Projekt Management GmbH (VPM) is to promote innovative ideas and facilitate development of promising projects. With this approach VPM has evolved into a successful biotechnology company which is internationally recognized.
Currently, VPM offers the opportunity to become part of its team involved in pharmaceutical development. This means being part of a company of team players and working closely together with experts from all areas of the development chain (research, non-clinical development, manufacture, regulatory, clinical development, patent law, marketing and business development) to successfully move our projects forward to market.
VPM is searching for a Quality Assurance Assistant to support the maintenance of the internal Quality Management System (QMS). VPM operates in the regulatory framework of ICH, the European Union and Germany. Therefore, VPM’s QMS implements the infrastructure and interfaces in the relevant GxP areas within the scope of Standard Operating Procedures (SOP) and other procedural documents.
- Assist to Quality Assurance (QA) in the field of GxP and ISO
- Administration and filing of QA relevant documentation
- Support to maintenance of VPM’s SOP system
- Performance of quality reviews on SOPs and other procedural documents
- Organization and maintenance of VPM’s archive
- Support to preparation of meetings, audits and reports
- Support to change control procedures
- Preparation of presentations
- Assist to project management
- Assist with national and international regulatory interactions
- Assist in review and evaluation of project proposals
- Be part of national and international team work
- Bachelor’s or master’s degree as medical documentarist/medical information manager or comparable qualification
- Excellent self-organization skills
- Ability to comprehend and oversee complex projects and prioritize required actions
- Enjoy working in cross-functional teams
- Excellent written and spoken English language skills
- Professional working knowledge of common software packages (Word, PowerPoint, Excel)