Job Title: Analytical QA Scientist
Reporting To: QA Supervisor
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
