Quality Assurance Officer

• Apr 2022 - Present

Equilab International is a leading Contract Research Organization (CRO) in Southeast Asia who provides bioavailability/bioequivalence study, clinical trial and analytical services. As a Quality Assurance my scope of work and responsibilities follows: - Responsible for the continuity and consistency of company activities procedure in accordance with Standard of Competence of Testing company activities ISO/IEC 17025, ISO 15189, Good Clinical Practice and Good Laboratory Practice. - Responsible for establish and direction the implementation of quality system in company activities. - Responsible for quality of study and testing in the company activities. - Performing the quality improvement program and quality assurance program (QA). - Responsible for archiving the QA records. - Responsible for updating the procedure. - Responsible for the QA audit in the clinical and analytical process. - Monitoring the corrective and preventive action for any non-conformity audit. - Responsible for monitoring in place and review clinical study - Conducting computer system validation. - Involve in development new system/application related to data integrity. Show less

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