Essential Duties and Responsibilities * Be responsible for the Calibration and Maintenance process of instrument and equipment, complete the related request and work according to the current valid procedures on time. This includes the coordination of activities performed by external partners as well as the internal calibration activities, i.e. temperature, humidity, HPLC. * Coordinate and support the qualifications of analytical instruments.Initiate Out-of-Tolerance (OOT) and support the instrument owner to assess the impact. * Coordinate the instrument repair process, take appropriate actions when instruments cannot be repaired. * Support Quality related tasks when needed, e.g., internal & external audit, change control, NCR/CAPA. * Review and approve metrology activities performed.Find improvement and/or simplification opportunities and implement them. * Manage all key activities of laboratory equipment and instruments during the full life cycle, i.e., installation, qualification, calibration, maintenance and repair. * Report and meet KPIs related to metrology and qualification.Qualifications * Good knowledge of Good Manufacture Practice, international regulation requirements and experience of calibration and qualification of Laboratory equipment. * Good at data analysis, for example for the purpose of document review, OOT review, instrument reliability review, risk assessment review etc. * Strong interpersonal skills and demonstrated ability to work in a team environment as well as in an international environment. * Excellent written and oral communication skills and in Chinese and English.Strong attention to detail. * MS with at least 3 years or BS with at least 5-10 years Experience in Metrology is required.Experience in Qualification of analytical instruments is desirable. * Lab experience essential, cGMP or CNAS experience desirable.
