QLS are recruiting for a Senior CSV Officer/Specialist to join a project with an Innovative Pharmaceutical Company based in Lausanne or fully remote on a temporary contract for 12 months.
The Company:
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. 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.
Main Responsibilities:
• 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.
Requirements:
• 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 is required
• 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
• Experience with regulatory requirements in the life sciences industry (GAMP 5,21 CFR part 11)
• Strong team player with sound analytical thinking and problem-solving ability
• You are used to simultaneously support multiple projects, duties and assignments
• Self-dependent way of working; taking ownership of assigned tasks
Benefits:
• Possibility to work from home with travelling to site 6-8 times a year (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.
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote job reference 00054890 in all correspondence.
