We are looking for a CSV Senior Officer in order to ensure the appropriate level of compliance for computerized systems validation (CSV) by assisting in the implementation and drafting of the required documentation.
Join the Quality Department of one of our prestigious clients, a biopharma based in the canton of Vaud.
Your responsibilities :
- Create key CSV deliverables and/or assist business units in writing CSV documentation (e.g., 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.
Your profile :
- At least a Bachelor in Sciences or in IT with minimum 8 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
- Working knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)
- Fluent in English, French is an asset