Computerized Systems Validation (CSV) Expert

responsibilities :

• Define, plan, and report CSV activities in alignment with regulatory expectations (e.g. FDA 21 CFR Part 11, Annex 11).
• Review and approve validation documentation (e.g. URS, risk assessments).
• Support of the CSV activities in the main CSV areas : Production Systems, Enterprise Systems Laboratory Systems.
• Support CSV activities by monitoring progress and escalating risks to ensure smooth business operations.
• Collaborate with users, subject matter experts, and suppliers to plan and implement validated systems.
• Review and approve key technical and quality documentation, including user requirements for computerized systems.
• Assess and define the level of validation required following system changes.
• Identify systems in scope for validation using a risk-based approach.
• Ensure risk-based approach to system validation and changes.
• Participate in internal and external audits, representing the QA CSV area.
• Provide guidance and training to site personnel on CSV requirements and data integrity.
• Monitor project progress and escalate risks to ensure timely delivery.
• Continuously develop your expertise in CSV and digital quality assurance trends.
• Initiate and review digital actions in TrackWise (deviations, change controls, CAPAs).

requirements-expected :

offered :

benefits :