Computer Systems Validation Lead
London, United Kingdom
ConvaTec Inc
/initiatives for CSV that will address areas of improvement and simplification of actual processes as the evaluation, development, and implementation of the Computer Software Assurance (CSA). This role is also responsible for providing the necessary oversight of system-related issues, employing risk-based methodology, leading teams … and changes and will review and approve CSV strategies/plans, devise compliance maturity assessments and remediation plans. Responsibilities Business Relationship: Collaborate with Quality Assurance Quality Systems, and Clinical QA Organizations to ensure that IT CSV and GxP processes and related procedures are in alignment with Quality/Regulatory … and Access Monitoring/Management. Experience with GAMP 5 and Computer Systems Validation within FDA (GxP) regulated environments. Knowledge/experience in CSA (Computer Software Assurance) and related processes/documentation. Knowledge and experience in GxP Guidelines; 21 CFR - Parts: 11, 210, 211, 820-QSR; Annex 11- ERES. More ❯
Employment Type: Permanent
Salary: GBP Annual
Posted: