必备条件:
几个关键词:CSV、计算机化系统验证、MES、数据库、SQL、自动化系统
接受短期项目,必须要现场面试。
优先条件:
1111
岗位职责:
Safety and Quality
Understand and remain compliant with safety culture, build safety mindset, and follow company & site safety journey.
Stay compliant with GMP and data integrity standards in their working area and strictly follow the quality standards to ensure compliance in their daily working.
Service; Project and CSV
Support IT PA project, following project plan and stick-on project task to execute, etc.
Execution on validation activity for IT project such as system configuration ,testing etc.
Draft, modify or update CSV related documents.
Operation tasks such as ARR, AR, PR, Audit Trail Review etc..
Address and resolve issues that arise during the computer validation process. Ensure all discrepancies are documented, tracked, and resolved in a timely manner.
Other MISC task assigned by function leader.
任职要求:
A minimum of 3 years of experience in computer system validation , better with the pharmaceutical or biotech industry.
Proficient in Computer System Validation (CSV) processes, including but not limited to risk assessment, validation planning, test scripting, execution and reporting.
Experience and ability to write documents in English.
Good capability of technical writing.
Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams.
Hold bachelor degree or above.
Possess high sense of GMP and DI.