The position

Tasks & responsibilities

• Based on your expertise in Computer System Validation, you ensure that changes are managed according to our validation rules in close cooperation with local experts in our GBS user community.
• Acting as a Validation Management Specialist, you support our daily operation of processes and applications.
• Ensure that our processes and systems are always compliant and in a validated state.
• Furthermore, you manage the execution and documentation of testing activities.
• You are familiar with Agile methods and tools, participating to projects driven with this methodology.
• You are familiar with working in projects and being measured against Key Performance Indicators (KPIs) / Service Level Agreements (SLAs) to strive for continuous improvement measures.

About our future employee

• Bachelor’s Degree; preferably in engineering, sciences, pharmaceuticals or biotechnology or equivalent and longstanding professional experience in regulations and processes.
• Profound experience in a pharmaceutical or biopharmaceutical production or supporting areas (e.g. quality assurance in production) required.
• A strong understanding of pharmaceutical regulations, including those mandated by the FDA, ICH, and European Pharmacopoeia would be an advantage
• Ideally profound knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21 CFR Part 11, CSA framework and EU Annex 11, and Data Integrity regulation.
• Experience in Quality Control systems (e.g. SAP, MYLIMS, OPSLIMS, GLOBAL-EM) required.
• Experience with agile methods (e.g. SCRUM, Kanban) and tools (e.g. JIRA) would be an advantage.
• Good analytical capabilities and problem-solving competence including a proper understanding of prioritization.
• Dedicated team player with good communication skills, and a structured way of working