天津招聘

Job Purpose and Key Responsibilities 岗位的目的和主要岗位职责:
? why job exists / what it must achieve岗位为什么存在 / 岗位必须完成的工作
Job Purpose 岗位目的:

1. Ownership of processes in the manufacturing facilities including process capability, process improvement initiative, process problems ownership and trouble-shooting.
2. Support the product transfer to support GMS network and to achieve the low-cost sourcing strategy from China

Key Responsibilities主要岗位职责:

1. Leading a team of Process Technologists, Pack Technologist in TSKF in support the site Technical activities and the product transfer activities.


2. Process Ownership
- Taking ownership for the manufacturing process on site to ensure process capability is achieved which including product quality trending, ownership of processing problems and trouble-shooting.
- Enhance the Process understanding for the manufacturing processing which include process robustness study, initiate process improvement, carry out trial and process validation.
- Define critical process parameters and implement standardization and control in the manufacturing process
- Provide technical input for Change control evaluation and initiation, including raw material changes
- Provide support for the Annual Product Review and understand the process capability and implement improvement plan.
- Support the GMS Technology strategy including implementation of PAT to improve the process control or enhance the process understanding
- Provide routine support for the site in term of QMS implementation, updating of relevant SOP, response to regulatory or customer request.
- Provide support for site Quality and EHS tasks achieving.


3. Products Transfer

- To lead a product transfer project to ensure it is delivered according to the planned schedule.
- Lead and support the standard product transfer according to GQMP requirement, RPS/NPGS or TSKF NPD to TSKF.
- Working closely with Network Change team, donor site and all the commercial markets for the transfer of product into TSKF in accordance to site procedures and standard.
- Taking ownership for the processes associated with product transfers, providing Process Introduction, Qualification and Validation data to meet timelines. Liasing with donating sites/NPD or above site support functions to obtain processing instructions, validation documentation for both product and cleaning validation analysis.
- Carry out process comparison assessment, plant fit and reviewing of processes, material specifications and registration details.
- Manage the product transfer activities to ensure manufacturing and packaging processes are transferred in accordance with cGMP/QMS/CAP/SAP requirements
- Preparation of product transfer documentation including, technology transfer documentation, qualification and validation documentation including protocols, batch records, SOP and so on.


4. Products Transfer and Capital projects

- Support the Capital project for facilities and equipment, e.g. design, sourcing of equipment, commissioning and validation (OQ/PQ).
- Preparation of project documentation including URS, qualification and validation documentation including protocols, batch records, SOP and commissioning or qualification documentation


5. Quality Process
- To comply with QMS and GQMP requirement as assigned, and participate & support the execution of site Quality plan


6. EHS Process
- Understand the applicable EHS requirements and Company policy, follow EHS standard operating procedures.

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

1. Process Ownership
- Accountable for commercial products’ process capability and process performance to deliver good quality product in a timely and effective manner

2. Products Transfer

- Accountable for the timely delivery of the product transfer in accordance to the project timeline and delivering activities as in the plan.
- Accountable for success of product transfer including defining the processes to be validated, identification of critical process parameters and knowledge management of information transferred

3. Capital projects and project management

- Develop the scope, cost estimate, schedule and execution plan for the project to fulfil the business needs.
- Prepare the business case and project investment proposals (PIP’s) for authorisation.
- Provide technical input to Procurement for the suppliers selection.
- Lead and motivate the team member to successfully deliver the project.
- Ensure that all staff working on the project are adequately trained and competent to carry out their role.
- Ensure that the project is carried out in compliance with quality and governance standards
- Ensure that the objectives or business benefits of the project are met
- Carry out AAR at the end of the project to establish learning points for future projects which can be shared throughout the GSK community.
- Liaise with other individuals or groups on or off site to establish best practice, share ideas, progress initiatives or resolve problems.

4. Technical Team
- In charge of a technical team in TSKF and represent Technical Function in the site leadership team.

所需知识的宽度（跨学科），所需知识的深度 （特定学科）

1. Bachelor or above education in engineering, science or pharmaceutical or related background.
2. At least 5 years experience in pharmaceutical manufacturing environment
3. Good process understanding knowledge and good analytical skills.
4. Good knowledge and understanding of GMP requirement
5. Team player and have a good understanding of other disciplines beyond their own core discipline in order to effectively lead a multi-disciplinary project team.
6. Project management skills and understanding of product transfer requirement
7. Understanding of the regulatory standards which apply to pharmaceutical manufacturing operations, registration requirement.
8. Understanding of manufacturing, packaging processes
9. Controlling of documentation.
10. Good communication and interpersonal skill, Good leadership
11. Good English level including oral communication, writing and listening
12. Good computer skills

葛兰素史克制药(苏州)有限公司是由葛兰素史克集团在苏州工业园区独资建造的现代化医药生产基地，该项目注册资金为1亿3千5百万美元，是葛兰素史克集团目前在华投资最大的项目，同时也是目前国内最大规模的外商投资制药企业。