Analytical QA Scientist

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