職位描述
Essential Duties and Responsibilities.
? Maintain instrument and equipment management system, manage the system users including the review and approval of the account request when necessary. Take as the system expert to guide the users for routine operation.
? Know well of Calibration and Maintenance process for instrument and equipment, completing the related request and work on time. Be familiar with the repair process, take accordingly actions when instruments failed to repair. Find the opportunities to improve instrument related work for compliance and simplification.
? Develop, update, review and approve instrument related files to ensure system’s compliance during the life cycle, including qualification files, change controls (ECC), periodic review, system decommissioning, SOPs, etc.
? Be familiar with Data Integrity (DI) requirements, executing DI remediation per accordingly plan, update qualification files and SOP when necessary. Managing laboratory computerized systems’ accounts, including rights review and account creation, modification, disabled.
? Support Quality related work when needed, e.g. risk management, audit, change control, NCR, CNAS.
? Good at data analysis.
? Good at English for speaking and writing.
Qualifications.
? Possess a good knowledge on Good Manufacture Practice and international regulation requirements and experience of system qualification/validation.
? Strong interpersonal skills and demonstrated ability to work in team environment.
? Excellent written and oral communication skills and strong attention to detail is desired.
? Demonstrates flexibility and the ability to shift gears between projects comfortably.
? English, written and spoken.
? Ability to challenge & probe
? Self-organization
Education and/or Experience.
? MS with at least 2 years or BS with >2 years relevant experienced in an Metrology/Qualification or equivalent.
? QSR research lab experience essential and cGMP experience desirable.
