System Validation Specialist
1 dia atrás
We are seeking a detail-oriented System Validation Specialist to join our Quality department.
- Validate computerized systems to ensure compliance with regulatory requirements.
- Maintain and update the Computerized Systems Validation Master Plan and Inventory.
- Prepare full lifecycle documentation: planning, risk analysis, functional/technical specifications, qualification protocols, final reports, and periodic reviews.
- Support and improve BPx system areas.
- Evaluate change requests and CAPAs related to system validation.
- Assist in deviation investigations and CAPA processes.
- Conduct audits to ensure validated status of embedded BPx systems.
- Participate in inspections and audits related to computerized systems validation.
Key qualifications:
- Advanced knowledge in computerized systems validation.
- Intermediate English proficiency.
- Proficiency in Microsoft Office (Word, Excel, Visio, PowerPoint).
- Desirable: Knowledge of PLC, HMI, basic programming, IT infrastructure, application servers, and databases.
- Self-confidence, teamwork, organization, focus, interpersonal skills, and proactivity.
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