Manager, CSV

Job Description

Responsible for the planning, execution and documentation of CSV according to internal procedures and external requirements (e.g. GxP, GAMP 5, 21 CFR Part 11) Working with all technology teams by reviewing work carried out when necessary to identify compliance issues and improvements by providing advice or training. Evaluate our validation procedures to ensure they are efficient across the product base identifying where improvements can be made. Ensure our validation process and approaches are fit for ensuring both quality and speed to value to the business while maintaining compliance. Working with technology teams ensure the upkeep of documentation and evidence as required by standard operating procedures are being carried out. Representing the department processes and created/adopted solutions in external client audits. Risk assessing solutions being adopted for use internally and advising on best approach to ensure compliant system adoption. Approving Validation Plans, accountable for ensuring that a robust risk assessment and mitigation strategy has been implemented. At least 6-7 years of computer system validation experience in a Life sciences and pharmaceutical environment. Good knowledge of cGxP regulations and software lifecycle approaches (e.g., GxP, GAMP 5, 21 CFR Part 11) Good communication skills