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บริษัท อินเตอร์เนชั่นแนล ไบโอ เซอร์วิส จำกัด

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Apr 1, 2025

Clinical Quality Assurance

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Phutthamonthon, Nakhon Pathom

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Job Descriptions
- Conduct internal audits (internal systems, trial master file, investigator sites, clinical service providers, inspection readiness) to assess the accuracy and quality of scientific data collected, and to determine the level of compliance with applicable regulations - Participates in the evaluation of quality events, incidents and possible complaints and the follow-up CAPA activities in the GCP finding and evaluate the impact of the audit findings, identifies and follow the CAPA activities - Provision inspection readiness training for internal client staff, site personnel, and potentially external vendors - Collaborate effectively with team partners and clients to ensure resolution of audits and ensure expected work products and output are aligned with regulatory guidelines, ICH-GCP and applicable regulatory requirements - Manages and maintains the quality system and prepares/assists in preparation of monthly/annual reports and quality trending reports and assist to identify quality system improvements - Reports the status of the quality benchmark of staff, systems and operation activities and participates in improvement programs - Involved in all new QA Clinical activities and in all Clinical QA related trouble shooting - Keep up to date with all related quality legislation and compliance issues
Qualifications
  1. BS in related field; Minimum 3 years experience organizing and conducting QA audits with solid experience in quality assurance and compliance related matters
  2. Must have prior clinical trial experience, ideally in BE study (will consider strong clinical background)
  3. Documented training in GCP and QA and a familiarity with clinical trial systems
  4. Prior international auditing experience desirable
  5. Current knowledge of ICH-GCP guideline, IRB and Thai FDA regulations
  6. Strong written and verbal communication skills, organization, analytical, problem solving and conflict resolution skills
BenefitsSee all Benefits.
How to apply
- สมัครด้วยตนเองที่บริษัท - ส่งใบสมัครทาง E-mail - สมัครผ่านปุ่ม Apply Now (Job thai)
Contacts
คุณชนิกา เชาวน์โชติสกุล
บริษัท อินเตอร์เนชั่นแนล ไบโอ เซอร์วิส จำกัด
888 หมู่ 6
Sala Ya Phutthamonthon Nakhon Pathom 73170
Tel. : 02-441-5211-19 ต่อ 230
Email : internationalbio_18@trustmail.jobthai.com (Email for job application & inquiry)
Fax : 02-441-5220
Location
Sala Ya Phutthamonthon Nakhon Pathom
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