Analytical QA Scientist

Job Title: Analytical QA Scientist Reporting To: QA SupervisorMain Responsibilities:Review Installation Qualification (IQ) and Operational Qualification (OQ) documents for instruments to ensure compliance with relevant standards and regulationsReview Preventive Maintenance (PM) records of instruments to ensure timely and complete maintenance activitiesReview instrument calibration records to ensure instrument performance meets requirements and data accuracyReview Out of Specification (OOS) investigation reports, track and drive effective resolution of issuesParticipate in and conduct on-site laboratory inspections to ensure laboratory operations comply with GMP and relevant quality systemsAssist in continuous improvement of the quality management system and promote quality compliance initiativesCoordinate and communicate with relevant departments to support investigation and corrective actions of quality issuesQualifications:2 to 5 years of relevant experience in analytical chemistry, familiar with instrument analysis and quality management processesBachelor’s degree or above, preferably in Analytical Chemistry or related fieldsFamiliar with Singapore Pharmacopoeia, United States Pharmacopeia (USP), and European Pharmacopoeia (EP).Familiar with GMP, quality management systems, and relevant regulatory requirementsStrong communication and coordination skills with a sense of responsibility; able to independently complete audits and inspectionsDetail-oriented and rigorous work attitude, capable of identifying and resolving quality issuesFluent in both Chinese and English, capable of professional bilingual communication and report writing