北京招聘

OVERVIEW

 

WuXi Clinical is currently looking for a Computer System Validation (CSV) Specialist with strong experience in computer systems and IT infrastructure to join our team in Shanghai, China. The candidate will be a member of the IT team responsible for ongoing support for information system compliance activities, including but not limited to, system validation or qualification, creating and implementing best practices within the framework of GxP, 21 CFR Part 11, and GAMP 5 regulations, risk assessment, vendor qualification, sponsor audit, change control, drafting test scripts and protocols, reviewing GxP documentation revisions, etc.

 

PRIMARY DUTIES AND RESPONSIBILITIES:

 

·       Responsible for planning, scheduling, execution and leading validation project assignments in coordination with business functions and in accordance with Good Clinical Practices (GCPs), FDA 21 CFR Part 11, and Good Automated Manufacturing Practice (GAMP5).

·       Validation assignments include validation, qualification, and implementation of new and existing, processes, equipment, software, and clinical information systems.

·       Leads cross-functional project teams in the development and implementation of the validation plan and protocols.

·       Prioritizes, manages and executes multiple projects utilizing Project Management methodology.  This may include assignment/oversight/review of validation projects to other personnel/teams.

·       Review and approve all validation documentation (plans, protocols, summary reports, etc), including vendor documentation.

·       Acts as the primary validation contact source for sponsors, vendors, the agencies (NMPA, FDA, etc.).  Provides support for regulatory submissions and regulatory agency inspections as required.

·       Maintains a thorough knowledge of the organization, policies and Standard Operating Procedures (SOPs), adheres to all organizational standards defined in SOPs and the WuXi Employee Handbook, and coordinates with IT team activities.

·       Support development of best demonstrated validation practices within the IT department, based on current industry practices and guidelines.

·       Champions continuous improvement of Company’s practices, documentation, forms, SOPs, and systems within the IT department (including validation) and throughout WuXi Clinical.

·       Review/harmonize SOPs, and author assigned SOPs to ensure compliance with Company policies and industry regulations.

·       Review of all system SOPs to ensure compliance requirements are met and qualified/validated state is maintained.

·       Develop/modify templates for system life cycle suite of documents including evaluation checklist and SOW (pre purchase).

·       Develop additional validation/qualification/system SOPs as required.

·       Provides business support and training to users for validated systems as assigned.

·       Schedule regular meetings with QA to identify and ensure compliance of system validation and qualification projects.

·       Maintain VMP, Vendor questionnaires as applicable.

·       Other projects related to compliance of systems and other duties as assigned.

OVERVIEW

 

WuXi Clinical is currently looking for a Computer System Validation (CSV) Specialist with strong experience in computer systems and IT infrastructure to join our team in Shanghai, China. The candidate will be a member of the IT team responsible for ongoing support for information system compliance activities, including but not limited to, system validation or qualification, creating and implementing best practices within the framework of GxP, 21 CFR Part 11, and GAMP 5 regulations, risk assessment, vendor qualification, sponsor audit, change control, drafting test scripts and protocols, reviewing GxP documentation revisions, etc.

 

PRIMARY DUTIES AND RESPONSIBILITIES:

 

·       Responsible for planning, scheduling, execution and leading validation project assignments in coordination with business functions and in accordance with Good Clinical Practices (GCPs), FDA 21 CFR Part 11, and Good Automated Manufacturing Practice (GAMP5).

·       Validation assignments include validation, qualification, and implementation of new and existing, processes, equipment, software, and clinical information systems.

·       Leads cross-functional project teams in the development and implementation of the validation plan and protocols.

·       Prioritizes, manages and executes multiple projects utilizing Project Management methodology.  This may include assignment/oversight/review of validation projects to other personnel/teams.

·       Review and approve all validation documentation (plans, protocols, summary reports, etc), including vendor documentation.

·       Acts as the primary validation contact source for sponsors, vendors, the agencies (NMPA, FDA, etc.).  Provides support for regulatory submissions and regulatory agency inspections as required.

·       Maintains a thorough knowledge of the organization, policies and Standard Operating Procedures (SOPs), adheres to all organizational standards defined in SOPs and the WuXi Employee Handbook, and coordinates with IT team activities.

·       Support development of best demonstrated validation practices within the IT department, based on current industry practices and guidelines.

·       Champions continuous improvement of Company’s practices, documentation, forms, SOPs, and systems within the IT department (including validation) and throughout WuXi Clinical.

·       Review/harmonize SOPs, and author assigned SOPs to ensure compliance with Company policies and industry regulations.

·       Review of all system SOPs to ensure compliance requirements are met and qualified/validated state is maintained.

·       Develop/modify templates for system life cycle suite of documents including evaluation checklist and SOW (pre purchase).

·       Develop additional validation/qualification/system SOPs as required.

·       Provides business support and training to users for validated systems as assigned.

·       Schedule regular meetings with QA to identify and ensure compliance of system validation and qualification projects.

·       Maintain VMP, Vendor questionnaires as applicable.

·       Other projects related to compliance of systems and other duties as assigned.

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务，包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册，通过严格的质量控制体系和专业团队的丰富经验，帮助创新性，突破性医药产品尽快上市和造福患者。

康德弘翼立足中国，面向世界，以上海总部为中心，辐射全球制药公司、生物技术公司以及医疗器械公司。目前，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系，始终保持着紧密的业务交流，保证了项目能高效、高质地完成。

随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。