Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
Excellent analytical skills.
Knowledge and understanding of the programming and reporting process
Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
Ability to learn new systems and function in an evolving technical environment.
Attention to detail.
Ability to successfully work as part of a global team.
Work effectively in a quality-focused environment.
Effective time management in order to meet daily metrics or team objectives.
Show commitment to and perform consistently high quality work.
Work rights
The opportunity is available to applicants in any of the following categories.