天津招聘

Key Responsibilities主要岗位职责:

Overall responsibility:

1. Responsible for assessment and execution of technical transfer and NPI manufacturing/packing process on site and assessing risk and its mitigation
2. Implement and maintain the Process understanding, capability and control for the implementation of NPI, ensuring the right level of detail is followed to ensure Zero defect at an early stage of manufacturing and packaging processing, this may include process robustness, maintenance, process improvement, supporting execution of trials and process validation.
3. Play planning role of each project and track closely.
4. Risk concept through project management process, support NPI Section manager identify and manage any potential risks from business, quality and EHS point of views.
5. Ensure risks are highlighted and managed through appropriate authoring of risk documents and ensure closed with evidence and filed appropriately

Project management:

6. Coordinate and finalize SIA for each product.
7. Raise change control and track all change actions, in line with GQMP and SOP requirement, ensuring change are completed appropriately.
8. Set up the detailed Microsoft project plan after team walk through, project team meeting etc.
9. Prepare day to day plan depend on different project progress, run daily project meeting at that stage. Working with planning, Logistics team to make sure build NPI in routine production plan.
10. Communicate and coordinate daily trial, PV etc activities, make sure no any mis-communication during transfer process.
11. Follow up closely on the project plan and make sure all step of project plan is completed on time, escalated any overdue, potential risk in a timely manner.
12. Track all project action log, risk log and decision log, maintain properly as the supporting documents of project. Archive all project evidence to support change closure.
13. Maintain NPI database, ensure all transfer dossier is archived properly in the formatted folder and ensure index up to date. All dossier and knowledge management information must be transferred with clear index to Quality after project closure.
14. Prepare TTS for NPI or product transfer at the project stage according to QMS and SOP requirements. Follow up the TTS approval according to required timeline and archive and handover to Quality team properly.
15. Provide required registration dossier from NPI point of view, i.e. repacking consignment with donor site etc.
16. Provide support and review of the registration documents supporting the NPI registration and validation.
17. Prepare PIP/PIF for project, maintain ePIP system, track spending of each project closely and report regular to NPI & Product transfer manager. Highlight any issue on the budget or cost perspective in a timely manner.
18. Support the authoring, review of related validation documentation related to manufacturing and packaging process (URS, PIP, IQ, OQ, PQ etc.) if necessary.
19. Provide routine support for the site in term of QMS implementation, updating of relevant SOPBOM/PPI/Batch record, response to regulatory or customer request such as R&D of external donor company.

Continuous improvement:

20. Conduct gap analysis on QMS for NPI and product transfer.
21. Update NPI KPI or technical KPI in a timely manner.
22. Use your sound understanding of the NPI process to support manufacturing process, ready for day to day technical activity, identification and progression of process improvement activities through the NPI registration which would be held for later implementation, to aid product introduction/transfer/extension; to gain product understanding, identify sources of variability and apply or define appropriate controls.
23. Provide support of Launch team to deliver product to market on time.
24. Provide that person with control strategy defined.

Other task assigned by NPI & product transfer manager.

Accountability 责任:

primary deliverables of role; it's scope; impact on strategy, policy, business or people relationships

责任范围，对公司战略、政策、业务及人际关系的影响程度

Scope责任范围(Budget, Team Management 预算，团队管理)：

1. Implement NPI identified from SIA or global network which will be taken by site and owned
2. Accountable to support NPI manager for project management through planning, action plan tracking, risk log management and decision log maintenance.
3. Coordinate and communicate with LOG VS, quality etc functions to ensure team at same page of project.
4. Control and track project budget.
5. Documentation management and control for NPI and product transfer.
6. Manage change control for projects.
7. Identify any risk through any stage of project management.
8. Support Product Owner for process validation/evaluation protocol and report.
9. Support Technical regarding, excipient, equipment and process and product knowledge prior to handover to product owner
10. Coordinate all NPI activities for campaigns including creating and managing D2D plans
11. Lead and manage NPI Investigations, including corrective and preventative actions and incidents and deviations that arise during a NPI
12. Support and prepare technical for NPI Audits at site and L4 level
13. Support collation and management of NPI product and process data in order to satisfy all statistical trending requirements e.g. for future PUCC, PPR
14. Ensure NPI activities that are required out of hours are supported
15. Understand and incorporate GMS requirements into the development of New Products
16. Identify area for increased commercial efficiency and decreased CoW in line with Zero Defects ready for commercial launch

Specialised Knowledge 专业知识:

breadth & depth across disciplines or functions; expertise in field required

所需宽度（跨学科），所需知识的深度 （特定学科）

1. Bachelor or above education in science, Project Management or pharmaceutical or related background.
2. At least 3 years experience in pharmaceutical manufacturing environment
3. Good process understanding knowledge and good analytical skills.
4. Good knowledge and understanding of GMP and local regulatory requirements
5. Knowledge and understanding of complex manufacturing and packaging processes
6. Good communication and interpersonal skill
7. Good English level including oral communication, writing and listening
8. Implement sustainable systems for product and process performance trending and analysis for products with the appropriate use of statistics
9. Will be capable of applying standard work routines to new and existing product processes
10. The role is based at GSK-T, and operates cross-functionally across the individual will also be expected to interact with, and influence individuals at different levels and different functions within the GSK organization such as CoE and R&D
11. The role also requires sufficient personal resource management skills to support individual projects and group deliverables.

GlaxoSmithkline/葛兰素史克
作为世界领先的制药业巨擘，葛兰素史克公司秉承以研究开发为基础的一贯理念，凭藉公司本身的技术潜力和资源优势，在当今瞬息万变的医疗保健领域保持强劲的增长势头。
葛兰素史克公司，由葛兰素威康和史克必成强强联合，于2000年12月成立。两家公司的历史均可追溯至19世纪中叶，各自在一个多世纪的不断创新和数次合并中，在医药领域都确立了世界级的领先地位。两个制药巨人的成功合并，为葛兰素史克成为行业中无可争议的领导者奠定了基础，并在全球药品市场中占据有7%的份额。
葛兰素史克公司总部设在英国，以美国为业务营运中心，在抗感染、中枢神经系统、呼吸和胃肠道/代谢四大医疗领域代表当今世界的最高水平，在疫苗领域雄居行业榜首。此外，公司在消费保健领域也居世界领先地位，主要产品包括非处方药、口腔护理品和营养保健饮料。2006年公司在全球的销售总额达232亿英镑。目前，公司在全球拥有10万余名既掌握专业技能又有奉献精神的出色员工。
全球研发中心有1万6千科学家和技术人员分布在全球许多国家。为进一步推动研发全球化，葛兰素史克(GSK)中国研发中心于2007年6月成立。中心将侧重于神经退行性病变的研究，目标是为多发性硬化病、帕金森病和阿尔茨海默氏病等严重疾病开发新药。中国研发中心将发展成有1000多科学家和技术人员的全球研发中心。中心将以科学研究为基础（science-driven），通过生物学，化学以及最新技术，创新开发新的治疗手段。中国研发中心将最终引领GSK在这一领域从识别药物靶标到后期临床研究的全球研发活动，并在中国和其他研究机构密切合作。GSK中国研发中心计划在未来10年内成长为GSK的大型研发中心之一。
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