Beschreibung
Your duties will be the following• Ensure the monitoring of quality of the work in accordance with the Quality Plan, Validation Plan and regulations in place (SOP) within the organization
• Ensures proper documentation cycle management (creation, naming, review, approval cycle)
• Ensures the right communication and information exchange between the different quality instances (E-Compliance, Information Governance Management)
• Works jointly with the Test Manager for all testing related activities Authors all Quality deliverables (Quality Plan, Validation Plan, Functional Risk Assessment, Quality Report, Validation Report)
• Contributes and supports to the establishment of qualitative Test documentation
• Reviews and approves all the project and system life cycle project deliverables
• Works closely with and reports to the Project Manager
• Provide Quality assistance and advice the team where applicable to ensure Quality procedures are correctly applying.
The skills you bring on board:
• Excellent interpersonal and communication skills and the ability to work well within a team environment.
• Excellent knowledge and understanding of Pharmaceutical Industry (CSV cycle) – GAMP / 21 CFR Part 11 Certified
• Knowledge of Trackwise is welcome in addition
• 5+ years of experience in a similar position, working with international teams, open and aware on different cultures.
• Fluent in English – excellent writing skills
• German language is optional but quite welcome