苏州招聘

职位描述：

Job Summary职位概述:

This position resides in the RDSZ IT organization and is responsible primarily for the compliance of GMP regulated computerized systems of Roche Diagnostics Suzhou. He/she also owns the quality and compliance perspective of internal IT processes as defined by Roche Group IT and RDSZ IT.

?Liaise with global IT quality and RDSZ local quality to be the owner of IT quality process, tools and standards to the stakeholders (e.g. Business, Demand, Solution Delivery, Solution Maintenance and Support, Governance)
?Develop/maintain quality procedures along the life cycle of computerized systems
?Review/approve IT system risk assessments and control activities
?Support project activities as validation lead, in particular for local GxP IT projects
?Support IT lifecycle processes such as change control and document management
?Provide training related to IT systems quality and compliance

Main Tasks & Responsibilities主要工作职责 :

Provide IT quality support to IT projects
?Act as the single point of IT quality support for all projects assigned, primarily as validation leader for assigned projects. Typical tasks includes managing project risks in GxP area, developing validation plan, summarizing validation results
?Act as a project team member from the start of the project, to give consultancy to IT governance processes such as PMM and CSV
?Understand scope, complexity and delivery approach of the project to effectively influence the IT quality best practices used in this project
?Support tailoring of project deliverables and the PMM paths according to the selected route, advising on the number of documents and the content material to be produced
?Escalate nonconformance identified during project which may risk the quality of the project

Ensure that internal and external standards are met
?Provide advice on the current standards such as PMM, documentation standards, Infrastructure Qualification, CSV policy and directive, system risk assessment, data privacy, GxP assessment, test documentation and change management
?Support RDSZ local quality team to review and approve respective IT areas within local business QMS
?Provide training / support to the team members on document standards and use of templates when required

In the quality document controller role, to ensure quality of all formal IT documents
?Support creation/review/approval of life cycle documents using the established templates in PMM
?Support creation of GxP related IT governance SOP following global/local templates
?Manage changes in HPSM in the role of “IT Quality”

System maintenance and operational support
?Provide IT quality support for system and IT infrastructure maintenance
?As single point of contact for change control and problem management process
?Support organizational risk management process
?Responsible as IT quality in configuration management, such as setting GxP flag and compliance tab for relevant configuration items
?Support local IT Quality initiatives as required

Support IT Quality Process Improvement and KPI Metrics collection and evaluation
?Identify process improvement opportunities and report into the appropriate Governance body
?Help in rolling out globally defined IT Quality processes as appropriate
?Collect and evaluate process specific or project specific numbers and figures as defined in general IT Quality Management and assist in evaluation and interpretation

GMP compliance reviews
?Perform GMP compliance reviews for local IT processes and documents as needed
?Support local quality team to perform periodic review for all GxP IT systems in scope
?Report any out of compliance activities or situations to the Site IT Head

Site Audit attendance
?Single IT point of contact for RDSZ audits and inspections
?Coordinate, escort the auditors and respond to queries regarding site IT audits

Basic Requirements of the Job基本任职资格:

Education& Qualifications教育背景与专业资格:
？Minimum Requirement: BS in Computer Science, Information Management or equivalent degree
？Expert knowledge in area of expertise and preferably a broad IT experience
？Industry recognized certifications in the relevant area are a plus (e.g. PMI, PRINCE2, ITIL, TOGAF, etc.)

Experience工作经验:
？5+ years of professional IT experience in a major, global organization
？3+ years of exclusive experience in IT quality specialized in Computer System Validation
？Experience in supporting international inspection and audit will be a plus
？Experience in rolling out complex validated IT system (e.g. OSI-PI, Environmental Monitoring System) will be beneficial
？Broad and strong experience in area of IT
？Project management exposure
？Goal oriented
？Responsible and reliable
？Strong communication skills
？Strong analytical and conceptual skills
？Exposure to working in an international environment
？Experience in the healthcare industry is assessed as a plus

Special Requirements
？Flexibility to work outside of normal working hours or on call arrangements to provide support
？Flexibility to travel for up to 10% of time including outside of home country

Leadership Competencies领导能力：

Leadership competencies at proficient level, in line with corporate framework.
参照罗氏集团领导能力标准和要求，领导能力达到熟练水平
Professional Competencies/skills专业能力/技能:
?Familiar with relevant regulations and industry standards, such as ISO 13485, IVDD, GMP(CFDA etc.), GAMP
?Proficient language skills (written and spoken) in Chinese, Advanced English reading, writing, listening and speaking skills
?Competent with routine application of MS Office, SharePoint, SAP, and other common office software, incl. databases

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作为体外诊断的全球市场领导者，罗氏诊断致力于为全球实验室和医院提供创新型检测和技术，从而帮助医疗专业人士为患者做出正确的医疗决策。

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