长沙招聘

PQE is looking for an IT System Decommissioning & Data Archiving Lead, willing to join our multinational consultants team

· Ownership and Leading decommissioning activities for each site for the in-scope applications

· Develop the strategic plan for the decommissioning of the applications in each site

· Engage with the site business PMs and the site data leads to develop the requirements documents for the applications to be decommissioned

· Ensure all in-scope applications to be decommissioned have been thoroughly assessed for the following: Data migration - Data archiving - Local application decommissioning regulations as applicable - Support contracts for the in-scope applications - Security requirements are met, including any user specific and data specific security requirements - License novation or closure of the decommissioned applications - develop the decommissioning checklist and RACI matrix for all involved stakeholders

· Manage all risks and issues arising out of the decommissioning activities

· Retain responsibilities in instances where physical handover of electronic data may be in scope for certain applications

· Ensure the timely disposal of the hardware according to the Company compliance and environmental policies

· Support the Archiving lead in the determination of the archiving scope for all applications, creating and tracking all the business requirements with the application/business product and site application owners, defining the governance for the engagement with the archiving service providers.

· Lead the analysis of the initial archiving data extracts received from the Company and ensure the extracts meet the reporting requirements for the in-scope application

· Support the Archiving Lead to develop the business case for the archiving service model

· Develop an Archiving playbook clearly documenting all in-scope applications, rationale for archiving, evidence logs, and approvals for future audit purposes

· Provide inputs to the sites and support them with any information needed for decommission purposes

REQUIREMENTS

· 3+ yrs exp in IT Project Management (Planning, Organizing, Leading, Controlling, Corrective Actions)

• IT System Lifecycle management (Migration/Implementation/Decommissioning) knowledge
• Multiple Teams Coordination

· Process Management (System Migration/Data Migration/Data Archiving)

· WBS, Gantt, Critical Path, RACI knowledge

· Risk Management, Cost Controlling and Budget Management

• Strong project management, planning and communication skills

· IT System Lifecycle management (Migration/Implementation/Decommissioning)

· ENGLISH language proficiency

NICE TO HAVE

· Previous experience in Pharmaceutical industries (local or multinational companies)

· 21 CFR Part 11 and Annex 11 Compliance and EU GMP Annex 11 Compliance knowldge

· Plan, Design Specification, IQ, OQ, PQ, URS, Deviation Management, Traceability Matrix; Validation Report general knowledge

FULL-TIME job
Location: Suzhou, China

PQE公司成立于1998年，作为欧洲领头的整体质量打包解决方案服务公司，以200多名专家咨询师的优势，服务领域包括质量系统、合规注册和验证确认等领域。更致力于为客户提供数据完整性保障(Data Integrity Assuance）的整体解决方案。我们已在全球45个国家，参与或主持了8，000多个项目。我们的客户包括全球知名跨国企业和地方领头企业。我们是山德士、特瓦等公司的全球服务伙伴，同时也与赛诺菲、辉瑞、罗氏、诺华等知名制药企业保持长期稳定合作关系。

PQE目前已进入中国市场，服务中国企业。我们期望能成为一个成本最优、品质最高的服务咨询公司。将秉承We Act Locally,Think Globally的商业理念。