Duration: 1 year
Location: Lausanne or remote
The company is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. The company aims to develop innovative therapies that target high unmet medical needs. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
For our Quality Management organization based at our Headquarters in Lausanne, we are looking for a CSV Senior Officer. You will contribute to the drug development activities related to innovative treatments in Oncology and Anti-infectives by supporting the CSV Lead in endorsing, maintaining and facilitating the appropriate compliance level for Computerized Systems Validation (CSV), assisting with the implementation and writing of required documentation.
Your responsibilities will be but not limited to:
• Create key CSV deliverables and/or assist business units in writing CSV documentation (Validation Plan, Functional Requirements Specification, Test Scripts, Validation Report), based upon approved templates / processes and ensures proper filing in respective document management system.
• Review vendor validation documentation and provide documented feedback and guidance.
• Execute Impact / Risk Analysis and document respective outcome.
• Support the analysis and monitoring of security processes and incidents.
• Support maintenance of e.g., system inventories, changes, incidents, etc, ensuring accuracy and completeness at all times.
• Participate as a “Tester” if deemed appropriate and investigate Test Defects, resolution and reporting.
• Provide CSV training as appropriate for users of specific systems.
• Apply and respect internal procedures and templates and ensure compliance in company working processes with GxP and related validation compliance.
• Closely collaborate with the CSV Lead, Business Process Owner and System Owner and understand the synergy between business, Quality and IT.
• At least a Bachelor in Sciences or in IT with 5-6 years working experience as CSV in the pharmaceutical industry
• CSV Experience in a GCP environment
• Auditing experience in the pharmaceutical industry is a plus
• Data Integrity experience project is a plus
• Excellent writing skills for scientifically sound technical documents, instructions, validation protocols and reports in English, French is an asset
• Self-dependent way of working; taking ownership of assigned tasks
• Possibility to work from home with visit in the office when needed (Lausanne)
• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
Please reach out to Adrien Guimard at AGuimard@ckqls.ch if this role could interest you.