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.
Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
Excellent communication skills, both written and verbal, in English
