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Validation Specialist
2 weeks ago
Contribute to Life Science projects for Antaes Asia clients
- Manage change control processes for computer systems, ensuring accurate documentation, risk assessment, and approval workflow.
- Coordinate with relevant departments to assess the impact of changes and ensure successful integration into existing systems.
- Support Corrective and Preventive Actions (CAPA) for computer systems, conducting root cause analysis and implementing effective solutions.
- Utilize and manage TrackWise for quality management processes, including deviations, CAPAs, and change control tracking.
- Develop and configure TrackWise workflows and ensure proper documentation.
- Develop and execute validation test scripts for Kneat to verify functionality, performance, and regulatory compliance.
- Document test results, deviations, and corrective actions, and ensure alignment with validation protocols.
- Contribute to the promotion of Antaes services on top of assistance provided to clients
**Job Requirements**:
- **Bachelor’s degree in Computer Science, Life Science, or a related field**:
- 1-2 years of experience in validation of computer system in the pharmaceutical industry
- Proficiency in Kneat, TrackWise, CAPA, and change control processes.
- Familiarity with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5).
- Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.
- Strong documentation and technical writing skills.
- Excellent communication skills, both written and verbal, in English
