Quality Assurance Analyst

2 weeks ago


Tuas, Singapore WuXi AppTec Singapore Pte. Ltd. Full time $60,000 - $90,000 per year

Main Responsibilities:

  • Review Installation Qualification (IQ) and Operational Qualification (OQ) documents for instruments to ensure compliance with relevant standards and regulations
  • Review Preventive Maintenance (PM) records of instruments to ensure timely and complete maintenance activities
  • Review instrument calibration records to ensure instrument performance meets requirements and data accuracy
  • Review Out of Specification (OOS) investigation reports, track and drive effective resolution of issues
  • Participate in and conduct on-site laboratory inspections to ensure laboratory operations comply with GMP and relevant quality systems
  • Assist in continuous improvement of the quality management system and promote quality compliance initiatives
  • Coordinate and communicate with relevant departments to support investigation and corrective actions of quality issues

Qualifications:

  • 2 to 5 years of relevant experience in analytical chemistry, familiar with instrument analysis and quality management processes
  • Bachelor's degree or above, preferably in Analytical Chemistry or related fields
  • Familiar with Singapore Pharmacopoeia, United States Pharmacopeia (USP), and European Pharmacopoeia (EP).
  • Familiar with GMP, quality management systems, and relevant regulatory requirements
  • Strong communication and coordination skills with a sense of responsibility; able to independently complete audits and inspections
  • Detail-oriented and rigorous work attitude, capable of identifying and resolving quality issues
  • Fluent in both Chinese and English, capable of professional bilingual communication and report writing


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