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Quality Assurance Specialist

Job Title: Quality Assurance Specialist
Contract Type: Permanent
Location: Bangkok Province, Thailand
Industry: Supply Chain & Procurement
Salary: THB50000.00 - THB70000.00 per month
Reference: JN -012020-447313
Contact Name: Thanyaporn Longprasert
Contact Email: tlongprasert@argyllscott.co.th
Job Published: February 04, 2020 17:57

Job description

Quality Assurance Specialist

The Client

International - well known Pharmaceutical company.

The Role

  • Develops an understanding of regulations pertaining to the implementation and use of computerized systems in GCP / GMP areas.
  • Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5.
  • Reviews and approves system lifecycle deliverables for new and modifications to existing computerized systems used in the GCP / GMP areas
  • Consults with CSQM team members and relevant internal stakeholders to identify/define high-risk areas with the intent on focusing on patient safety, product quality, and data integrity.
  • Participates in performing Periodic Review activities of Computerized Systems
  • Provide support to regulatory inspection preparedness activities as needed
  • Experience performing Infrastructure Qualification activities

The Person

  • Bachelor's Degree in Pharmacy or Science or any other related field
  • Minimum 3 years Quality Assurance experience in the pharmaceutical or healthcare industry
  • A few years of experiences in pharmacovigilance activities
  • Good understanding of GMP regulations, guidelines and policies governing the healthcare industry (pharmaceutical, cosmetic, medical device)
  • Great communication skills - about to coordinate with both internal cross-department and with clients

APPLICANTS WHO DO NOT MEET THE ABOVE CRITERIA WILL NOT BE CONSIDERED.

If you have any queries, please call Khun Thanyaporn on +66 (0) 2 107 2571 or tlongprasert@argyllscott.co.th

Argyll Scott Asia is acting as an Employment Agency in relation to this vacancy.