湖州招聘

职位描述：
要点：本科及以上学历，做保健品固体制剂的，要求英语工作交流。
Key Responsibilities主要岗位职责:
1、Process Ownership
- Taking ownership for the manufacturing process on site to ensure process capability is achieved; 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, and carry out trial and process validation.
- Support the implementation of effective PLM through the identification and optimisation of critical process parameters along with use of inherent knowledge to drive standardisation and control of these in the manufacturing process through tools such as Technical Risk Assessment (TRA), Data Trending (PPA) and Root Cause Analysis (RCA)
- 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.
2、Product Technical 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 ** NPD to **.
- Working closely with Network Change team, donor site and all the commercial markets for the transfer of product into ** 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.
- Be a champion and main lead for the implementation of new/alternative technologies for existing ** production processes. Be prepared to challenge the existing production methods and use connection
3、Product Transfer and Capital projects
- Timely delivery of the product transfer in accordance to the project timeline and delivering activities as in the plan.
- Product transfer including defining the processes to be validated, identification of critical process parameters and knowledge management of information transferred
- 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
- Manage the implementation of global led project associated with product/process improvement and optimisation (e.g. CRSF.)
4、Supervise implementation of GMP, Medical Device, SOP and safety policy; ensure it meet national and ** standards.
监督GMP、医疗器械法规、SOP及安全环保政策的执行达到国家和**的标准。
5、Accountable for functional risk management, includes proactive risk identification, assessment and mitigation plan development.
确保所在部门风险管理体系的有效性,包括积极主动对风险进行识别、评估和制定缓解行动计划
6、Responsible for team development, improve team engagement
负责团队人员的发展计划，持续发展员工技能，提高团队人员的工作积极性和敬业度。
7、Understand and comply with the applicable local regulations of Quality, EHS and others, ** standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures.
理解并遵守适用的质量、环境、健康及安全等方面的当地法律法规、**质量管理体系及环境健康安全等方面的标准和公司方针，遵守公司标准操作规程。
8、Other projects and tasks as assigned by the line manager.
其它由直线经理安排的项目和工作。

Requirement:
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 举报 分享

  Changshu Tonghe Human Resource Service Company (Tonghe Headhunting) is a legally registered and private-owned company with business in Human Resource Consulting & Service area. Established in 2004, with more than 10 years development in Changshu City, now it is a locally well-known headhunting company in Suzhou city. As a local headhunting company, Tonghe Headhunting has successfully supplied good qualified candidates for most of the Foreign Invested Companies in the Yangtze River Delta Area through its professional and practical operation. Due to its efficiency & effective work & consistence in candidates sourcing, Tonghe Headhunting has already set long-term relationship with many well-known multinational companies, such as Novartis of Switzerland, Dowcorning of USA, UPM of Finland, Continental Of German & Danieli of Italy etc. Tonghe Headhunting has been successfully elected as the Vise-Chairman of the Changshu Human Resource Service Association ever since 2011. Within HR circle in Changshu & Yangtze River Delta Area manufacturing fields, Tonghe Headhunting enjoys very good reputation and inflection.
 
  常熟市通和人力资源服务有限公司是经合法登记注册的民营股份制人力资源咨询和服务机构。通和公司成立于2004年初，经过十多年的快速发展，目前已是苏州地区知名的人才猎头公司。 通和公司通过其专业而务实的服务已经成功地为在苏州及长三角地区投资的知名外资企业和大型民营企业提供了众多的优秀人才。 由于在人才招聘方面的高效，准确和持续搜寻能力，通和公司和许多知名外企建立了良好而长期的合作关系。迄今为止，通和公司已经为瑞士诺华制药公司，美国的道康宁公司，芬兰的芬欧汇川纸业，德国的大陆汽车及意大利的达涅利公司等众多知名企业提供了卓有成效的人力资源服务。自2011年起通和公司被评选为常熟市人力资源协会副会长单位。 在当地的人力资源行业及长三角的制造业内通和公司享有良好的声誉和影响力。

Our Mission
    To be a good supplier in HR integrated Service Area.
    To be the friend & consultant for the Professional Talent and High-Level Manager.

我们的使命（ Our Mission ）
    人力资源综合事务的优秀供应商
    高级管理和技术人才职业顾问和益友
  
Our Vision
    Be the influential headhunting company in the manufacturing fields with focus on Chemical & Pharmaceutical & Auto & mechanical.
    Be the well-known human resource supplier in Yangtze River Delta Area in the future.
 
我们的远景（ Our Vision ）
    制造业内知名的专业猎头公司（主要涵盖化工、医药、汽车、机械）
    成为长三角地区知名的人力资源供应商