默克投资(中国)有限公司新闻资讯

Femibion伊维安欢迎最新从事过药品生产/质量管理等行业的优秀人才加入我们，默克投资(中国)有限公司将为您提供广阔的发展平台！

Overall job purpose/工作目标概括：

Provide quality oversight to Computerized System and Data Integrity to ensure all the activities within the life cycle of the Computerized System and Data Integrity are compliance with LS quality standards and customer expectations.

Responsibilities/工作职责：

？ Computerized System Life Cycle Management: (80%)
? Establishing management system for the life cycle of the computerized system and GMP Data.
? Working closely with Validation Group, System Owner and Business Owner to achieve and maintain Computerized Systems and Data Integrity compliance.
? Lead/organize/support of resolving all issues related to Computerized Systems and Data Integrity compliance during routine quality operation, internal/external audits and self-inspections.
? Conduct assessment to new computerized system and determine validation strategy, establish validation requirements based on established SOPs and local standards to ensure compliance and maintain an inspection readiness state.

？ SU center IT projects CSV management: (20%)
? Participate SU Center IT project as CSV/DI Expert role, and work into developing, reviewing, and managing CSV activities (SAP/EBR/QIBS/WMS/TMS/WCS/BMS/EMS) , and ensuring that the validation activities meet with LS CSV and DI requirements.

Skills, Performances & Competences required by the position:
岗位所需技能，绩效及能力:
? BS or above in Life Science/Pharmaceutical/Computer or equivalent.
? 5+ years’ experience in Quality/Technical/Operation in pharmaceutical, medical device, or life science industry.
? Familiar with GMP/ISO and quality management.
? Fluent in English.
? Result orientation, accuracy and reliability as a must.
? Excellent communication, problem-solving, planning and organization skills.
? Site expansion/tech transfer projects experience, or CSV of medical device/filter/Single Use products preferred.