Aug 4, 2022
QA Section Chief
Phutthamonthon, Nakhon Pathom
1.Evaluate test facilities system and study related activities systematically and independently to determine whether they were performed accurately and complied with the standard operating procedures (SOPs), OECD-GLP principles, ICH-GCP principles and applicable regulatory requirement(s) 2.Assign/select the person who conducted the inspection/ internal audit, and train whom performed the inspection/internal audit 3.Report any results in writing to management and to Principal investigator/Study Director and the respective management 4.Inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies. 5.Assist in identifying, developing and implementing continuous quality improvement activities using relevant tools 6.Collaborate effectively with team partners and clients to ensure resolution of audits and ensure expected work products and output are aligned with OECD-GLP, ICH-GCP and applicable regulatory requirements
- Bachelor Degree or higher in Applied Science or related field knowledge of ISO, FDA and GLP/GCP concepts and applicable regulatory requirement(s)
- Minimum 3 years experience organizing and conducting QA audits with solid experience in quality assurance and compliance related matters
- Must have prior clinical trial and bioanalytical analysis experience, ideally in Bioequivalence study
- Strong communication, prioritization and organizational skills
- Demonstrated knowledge and experience in the application of Quality system, Risk assessment and Root cause analysis principles and practices
- Work on complex assignments in collaboration with various department system owners. .
- Age 27-35 years
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Salaya Phutthamonthon Nakhon Pathom 73170
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Salaya Phutthamonthon Nakhon Pathom
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