職位描述
Description:
The Principle Systems Analyst - IT OPS Compliance Asia Pacific (Virtual Team Member) ensures operational compliance execution within IT OPS function as well as monitoring of adherence and performance to Quality Management (QM) KPIs to support IT OPS in the AP region.
This will be ensured by providing implementation, consulting and services.
The position holder will interact with the IT Quality & Compliance function and with the international operations sites in regard to compliance execution activities.
- Ensure appropriate KPI monitoring and reporting.
- Ensure training and support of IT OPS staffs in regard to GxP related questions.
- Support projects in regard to quality related questions.
- Coordinate internal audits and assessments within IT OPS.
Duties & Responsibilities:
?Implementation: Assess relevance and impact of Corporate IT and Business Regulations with impact on IT OPS. Communicate and train Corporate IT Regulations within in IT OPS. Initiate, review and release system specific regulations within IT OPS. Monitor and communicate adherence and performance of quality and compliance, e.g. by monitoring training status, CAPA, change compliance and periodic reviews. Close alignment and communication with IT Internal Quality & Compliance function and System Owners, Validation Managers in OPS sites. Provide OPS requirements to author of Corporate IT regulations in preparation of creation/update.
? Consulting: Consulting, Training and guidance within IT OPS in terms of regulatory compliance, regulations and use of IT standard tools. Consult to support qualification activities. Collaboration with local Validation Managers for handling of SLC documents.
?Services: Support important projects and programs to ensure compliance with regulatory and BI internal regulations within IT OPS. Support external audits and inspections in the area of IT OPS. Coordinate internal audits and self-inspections in IT OPS. Track remediation activities in IT OPS.
Act as global business partner for meeting business needs and goals.
?Support IT OPS Manufacturing - Engineering Integration Services as contact person for the local engineering community. The objective is supporting the delivery and implementation of technology solutions in support of the business objectives to improve productivity and enhance processes.
Requirements:
?Broad knowledge and experience in GxP compliance topics of Pharmaceuticals and Animal Health
- Knowledge of ITIL framework (preferably ITIL Foundation certification)
- Global/regional/local thinking scope
- Communication skills and Conflict Management
- Experience in Project Management
- Intercultural skills
- Consulting skills
- Experience in IT Quality Management and life-cycle management of IT applications
?Technical understanding and knowledge of
- Linux, Windows and Windows Terminal Server
- Java platforms ( JBOSS , Java Application Server )
- Databases (Oracle, MS SQL )
- Basic knowledge of network technologies,Citrix and VMWare environment
- Good understanding of IT infrastructure components, processes and technologies
企業介紹
Shanghai Information Chain Network Technology Co. LTD is an information technology company specialized in providing enterprises for IT products, scheme of resolution and consultation. Since its beginning, Shanghai Information Chain has absorbed itself into supplying professional IT service to enterprises. We provide suitable service to enterprises by means of accumulating IT experience and powerful groups of consultants. It is believed that the value of IT technology should be focused on how to master technology and producing benefits to human being instead of technology itself. In conclusion, we are faithfully convinced that service creates value. Please pay attention to www.inforchain.com and www.itmc.com.cn and you can get to know our two main businesses by exploring them.
www.inforchain.com; www.itmc.com.cn