We are looking for a Software Validation Manager to lead and govern Computer Software Validation (CSV) and Computer Software Assurance (CSA) programmes for GxP computerised systems. Oversee validation activities, ensure regulatory compliance, and drive continuous improvement. Ideal for experienced professionals with strong leadership in regulated technology environments.
Skills
- computer software validation
- computer software assurance
- gxp regulated environments
- software development life cycle
- risk-based validation methodologies
- fda 21 cfr part 11
- fda qmsr (21 cfr part 820)
- eu annex 11
- gamp® 5 (second edition)
- iso 13485
- alcoa+ data integrity
- cloud-based applications
- saas platforms
- erp systems
- qms
- plm
- ai-enabled applications
- data migration
- data integrity controls
- change management
- deviation management
- capa processes
- vendor oversight
- internal audits
- compliance remediation
- project management
- alm tools
- windchill
- etq
