Found Description
Overview
As a Validation Specialist, you will be responsible for supporting the validation lifecycle and ongoing compliance activities for computerized GxP systems used across the organization. This includes risk assessments, validation testing, change control support, audit inspection and compliance.
Responsibilities
Qualifications
As a Validation Specialist, you will be responsible for supporting the validation lifecycle and ongoing compliance activities for computerized GxP systems used across the organization. This includes risk assessments, validation testing, change control support, audit inspection and compliance.
Responsibilities
- Work closely with QA, IT, External Vendors & System Owners
- Support development and implementation of risk-based validation framework for AI enabled GxP systems
- Support validation activities for GxP computerized systems, including system period reviews
- Track and manage validation deviations and defections through to closure
- Support Internal Audits and regulatory inspections
- Support updates to SOPs, work instructions and validation templates
Qualifications
- Experience working within a clinical trials environment (CRO, pharma or academia)
- Understanding computer system val...