Site Launch & Change Controller
葛兰素史克全球生产及供应(中国)
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2013-03-26
- 工作地点:天津
- 招聘人数:1
- 职位类别:项目经理/主管
职位描述
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:
To deliver the new SKUs of existing products transfer or introduction projects in GSKT, lead site multifunction team and in conjunction with market, provide support covering project initiation, planning, implementation, communication, organizing and accountable for meeting agreed market launch dates.
Effectively manage the pack change process to creates, coordinate and deliver pack component artwork for both the existing products at GSKT and new SKUs of existing product or products transferred to GSKT.
To ensure the artwork are prepared with high accuracy, in compliance with the GSK Corporate Product Standards (CPSs) and local regulatory requirements, and meet with commercial launch plans.
To ensure the smooth of Global Pack Management (GPM) process through the management of electronic artwork creation and transfer.
Key Responsibilities主要岗位职责:
1. Ensure team members work towards and meet agreed lead times and annual KPI’s, at the same time setting corresponding weekly and monthly targets for team members and ensuring the targets are visible, reportable and adhered to.
2. Liaise with GMS Strategy Network Rationalization team, Global Post-Approval Regulatory( GPAR) , donor sites or above site support functions, agree the master plan to achieve GMS Network Rationalization initiatives.
3. Liaise with GPAR or market regulatory for product registration and approval. Be able to negotiate with markets, GPAR for the benefit of company
4. Liaise with Quality for GMP inspection / audit by authority of the market.
5. Lead site multifunction team and in conjunction with market to meet agreed launch plan for new SKUs of existing products transfer or introduction in GSKT.
6. Maintain good networking and able to build relationships across functions, both external and internal, and across cultures.
7. Identify and communicate with all key stakeholders/customers on a timely basis.
8. Prepare site documents at highest quality for registration purpose.
9. Know details of each task and be able to link them together for the accurate monitor of the progression of project.
10. Able to detect artwork errors prior to approval to prevent product recall.
11. Support Artwork Specialist for all site artwork change and artwork for new SKUs, and remain abreast of the GPM process as the initiator, also including artwork in Agile & non agile.
12. Communicate & Work with market MLCC and RSCI to develop/update artwork according to market local regulatory requirement, ensuring that all GSK policy, processes and Electronic Artwork Transfer (EAT) standards are complied with.
13. Carry out the proof read of artwork/technical drawing, approval process and pre-press proofs as and when required to meet agreed time lines.
14. Co-work with Site Pack Technologist to develop new/amended cutter guides/drawings
15. Control the use of anti-counterfeiting features and ensure all artworks are prepared in line with site guideline.
16. Support marketing team upon receiving a request.
17. Issue and keep records of pharma and pack component codes
18. Remain abreast of changes to cGMP, manufacturing, QA, company policy and regulatory requirements for local, EU and international markets to assure the delivery of registration documents of the highest quality and reliable processes.
19. Perform self audit and QMS gap evaluation in the areas of responsibility to maintain constant quality standards and continuously develop and implement more effective and efficient ways of improving.
20. Work safely and use all equipment in a safe and responsible manner. Report immediately any unsafe situations or accidents.
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. Drive and implement the new SKUs of existing products transfer or introduction projects (not limited to), including project feasibility, project development, planning, internal/external communication, planning, coordination etc.
2. Overall coordination and planning for new SKUs introduction, including
? Work out timetable
? Regular update of progress
? Arrange new SKUs introduction meeting periodically
? Coordination with Value Stream teams and all levels of functions, Regulatory, QA/QC, Logistics, Finance, procurements, etc.
3. Escalate issues to stakeholders including site director during project implementation in order to remove the barriers and deliver projects.
4. Attend meeting & Teleconference for communication within project community
5. Publish project monthly report
6. Successful product supply to the market.
7. Accountable person for meeting agreed market launch dates through the use and development of local site project management plans.
Specialised Knowledge 专业知识:
? breadth & depth across disciplines or functions; expertise in field required
所需知识的宽度(跨学科),所需知识的深度 (特定学科)
Education and Work Experience
- Prior experience in the creation of artwork, packaging technology and proof reading of pharmaceutical products.
- - Project management experience.
- Computer skills (especially Apple Macintosh) using software for artwork creation (e.g. Quark X Press, PageMaker or Illustrator)
- Good written and spoken English.
- Maintaining / troubleshooting artwork studio systems
- Knowledge of GPM process and site related SOP
? 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:
To deliver the new SKUs of existing products transfer or introduction projects in GSKT, lead site multifunction team and in conjunction with market, provide support covering project initiation, planning, implementation, communication, organizing and accountable for meeting agreed market launch dates.
Effectively manage the pack change process to creates, coordinate and deliver pack component artwork for both the existing products at GSKT and new SKUs of existing product or products transferred to GSKT.
To ensure the artwork are prepared with high accuracy, in compliance with the GSK Corporate Product Standards (CPSs) and local regulatory requirements, and meet with commercial launch plans.
To ensure the smooth of Global Pack Management (GPM) process through the management of electronic artwork creation and transfer.
Key Responsibilities主要岗位职责:
1. Ensure team members work towards and meet agreed lead times and annual KPI’s, at the same time setting corresponding weekly and monthly targets for team members and ensuring the targets are visible, reportable and adhered to.
2. Liaise with GMS Strategy Network Rationalization team, Global Post-Approval Regulatory( GPAR) , donor sites or above site support functions, agree the master plan to achieve GMS Network Rationalization initiatives.
3. Liaise with GPAR or market regulatory for product registration and approval. Be able to negotiate with markets, GPAR for the benefit of company
4. Liaise with Quality for GMP inspection / audit by authority of the market.
5. Lead site multifunction team and in conjunction with market to meet agreed launch plan for new SKUs of existing products transfer or introduction in GSKT.
6. Maintain good networking and able to build relationships across functions, both external and internal, and across cultures.
7. Identify and communicate with all key stakeholders/customers on a timely basis.
8. Prepare site documents at highest quality for registration purpose.
9. Know details of each task and be able to link them together for the accurate monitor of the progression of project.
10. Able to detect artwork errors prior to approval to prevent product recall.
11. Support Artwork Specialist for all site artwork change and artwork for new SKUs, and remain abreast of the GPM process as the initiator, also including artwork in Agile & non agile.
12. Communicate & Work with market MLCC and RSCI to develop/update artwork according to market local regulatory requirement, ensuring that all GSK policy, processes and Electronic Artwork Transfer (EAT) standards are complied with.
13. Carry out the proof read of artwork/technical drawing, approval process and pre-press proofs as and when required to meet agreed time lines.
14. Co-work with Site Pack Technologist to develop new/amended cutter guides/drawings
15. Control the use of anti-counterfeiting features and ensure all artworks are prepared in line with site guideline.
16. Support marketing team upon receiving a request.
17. Issue and keep records of pharma and pack component codes
18. Remain abreast of changes to cGMP, manufacturing, QA, company policy and regulatory requirements for local, EU and international markets to assure the delivery of registration documents of the highest quality and reliable processes.
19. Perform self audit and QMS gap evaluation in the areas of responsibility to maintain constant quality standards and continuously develop and implement more effective and efficient ways of improving.
20. Work safely and use all equipment in a safe and responsible manner. Report immediately any unsafe situations or accidents.
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. Drive and implement the new SKUs of existing products transfer or introduction projects (not limited to), including project feasibility, project development, planning, internal/external communication, planning, coordination etc.
2. Overall coordination and planning for new SKUs introduction, including
? Work out timetable
? Regular update of progress
? Arrange new SKUs introduction meeting periodically
? Coordination with Value Stream teams and all levels of functions, Regulatory, QA/QC, Logistics, Finance, procurements, etc.
3. Escalate issues to stakeholders including site director during project implementation in order to remove the barriers and deliver projects.
4. Attend meeting & Teleconference for communication within project community
5. Publish project monthly report
6. Successful product supply to the market.
7. Accountable person for meeting agreed market launch dates through the use and development of local site project management plans.
Specialised Knowledge 专业知识:
? breadth & depth across disciplines or functions; expertise in field required
所需知识的宽度(跨学科),所需知识的深度 (特定学科)
Education and Work Experience
- Prior experience in the creation of artwork, packaging technology and proof reading of pharmaceutical products.
- - Project management experience.
- Computer skills (especially Apple Macintosh) using software for artwork creation (e.g. Quark X Press, PageMaker or Illustrator)
- Good written and spoken English.
- Maintaining / troubleshooting artwork studio systems
- Knowledge of GPM process and site related SOP
公司介绍
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。
联系方式
- 公司网站:http://www.gsk.com
- 公司地址:苏州工业园区苏虹西路40号
- 邮政编码:215021