Unison Laboratores Co., LTD.

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Mar 13, 2025

Quality Assurance Personnel (ปฏิบัติงานที่สุขุมวิท 62)

สถานที่ปฏิบัติงาน

Phra Khanong, Bangkok

เงินเดือน

15,000 - 25,000 THB

อัตรา

1 อัตรา

สมัครงาน

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Job Descriptions

•Quality assurance personnel (QA) is independent and under the direct responsibility of Test Facility Management (TFM). •Perform QA activities to comply with the Quality Assurance Programme (QAP) under OECD Principles on Good Laboratory Practice (OECD GLP) within a test facility which means a set of planned actions of the QA monitoring that include verification, inspection and documentation. •Verify all standard operating procedures (SOP) to ensure that all SOPs comply with OECD GLP principles. •Validate the calculation forms to ensure that formulas and software are valid. •Prepare the QA inspection plan and conduct inspections to ensure all studies are conducted in accordance with OECD GLP principles. Types of inspection are shown as follows. oFacility-based Inspection oStudy-based Inspection oProcess-based Inspection Verification and inspection must be recorded and the results and/or summary of inspection must be informed or reported to a relevant or responsible person. •Prepare the QA Inspection List as a summary of planned QA activities. •Ensure that the study is conducted in accordance with Good Clinical Practices: review and audit activities related to the conduct of clinical studies (Phase I, II, III and IV) in human subjects under the control of the company including: system audits of all operations relating to the collection, storage, analysis and reporting of clinical data subject to be reviewed by regulatory agencies; study-specific/in-house audits including reviews of protocols, correspondence files, monitoring reports, drug reconciliation, case report forms, adverse reaction reports, summary reports, etc.; study specific/on-site audits for the purpose of verifying the accuracy of reported study data against source documentation. •Verify the study plan before the study is conducted (before the experimental starting date of the study) to ensure the study plan contains the information required for the study and complies with OECD

Qualifications

Having at least a bachelor's degree in scientific field
Having knowledge or training in GCP and GLP principles or other laboratory standards.
Having knowledge or training in an analytical laboratory
Enthusiastic and able to confront problems.
Able to use basic computer software
Able to read, write and listen to English.