丁香人才 > 职位招聘 >医药公司/药店/医疗器械招聘 >上海医药公司/药店/医疗器械招聘 >Senior Validation Specialist/Manager招聘

Senior Validation Specialist/Manager

GE通用电气(中国)医疗集团 2016-12-05发布 2017-01-20截止
  • 学历要求: 不限
  • 外语要求: 不限
  • 年龄要求: 不限
  • 专业要求: 不限
  • 工作年限: 不限
  • 月薪范围: 面议
  • 职位性质: 全职
  • 工作地点: 上海市
  • 职称要求: 不限
  • 招聘人数: 若干

职位描述


Role Summary/Purpose: Responsible for building up and leading GE life sciences validation services in China for China market to support China overall bioprocessing business growth. This role is the expert in single use validation, bioprocessing systems and consumables validation, and potentially the leader to build up and mange GE validation services to offer GE as a total solution provider.
Essential Responsibilities:
- Work closely with commercial team and biopharmaceutical end users, to understand and identify the important areas of validation required to serve the market needs.

- Work closely with global regulatory and validation experts, to translate the knowledge and application into China market, as well as feedback China needs for central prioritization.

- Proactively engage with biopharmaceutical customers to offer GE validation services and capability, to help their clinical pathways.

- Shortlist and prioritize the validation services (extractables/leachables, filtration validation, etc.) to be set up based on the market need to better support GE LS growth. Identify the right testing suppliers (both internal and external) and manage all through to achieve the best result for both GE and customers.

- Set up the validation testing protocols, project management for the actual testing processes, through to deliver the approved report to biopharm. Customers.

- Initial responsible for developing and improving extractables/leachables documentation and testing; Write and revise protocols, procedures, reports and other documentation as necessary to support the customer; Identify critical process parameters and conducting experimental analyses; Utilize scientific principles and experience to independently execute and optimize experiments in the process of validation; Work with internal associates and external experts to manage the challenges including unexpected experimental difficulties, technical hurdles, trouble shooting and conflicts within test project; Cooperate and communicate with project coordinator to ensure project progress.

- Deliver validation trainings to customers and speeches during key events and conferences.

- Drive for opportunities to interact with regulatory agency (CFDA) and biopharm. Customers to understand the latest guidelines/policies for bioprocessing and single-use regulations.

- Establish the validation services capability for GE life sciences in China. Shape GE as the leading validation services provider in the biopharm. Market.

- Shortlist and prioritize the validation services (extractables/leachables, filtration validation, etc.) to be set up based on the market need to better support GE LS growth.

- Provide expert technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing project.

- Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.

- Responsible for developing and improving extractable documentation and testing; Write and revise protocols, procedures, reports and other documentation as necessary to support the customer; Identify critical process parameters and conducting experimental analyses; Utilize scientific principles and experience to independently execute and optimize experiments in the process of validation; Work with internal associates and external experts to manage the challenges including unexpected experimental difficulties, technical hurdles, trouble shooting and conflicts within test project; Cooperate and communicate with project coordinator to ensure project progress.
Qualifications/Requirements:
- Problem solving ability and excellent oral and written English communications skills

- Minimum Master Degree in Science, Engineering or a relevant Quality discipline.

- Minimum 5 years experience in a similar role.

Key Competencies:

- Ability to Lead a team

- Customer service

- Honesty and consistency

- Planning and prioritisation.

- Drive for results

- Creative and analytical thinking,

- Focus on quality

- Attention to detail
Additional Eligibility Qualifications:
Desired Characteristics:
- Proven and progressive previous experience in validation/services/QA/RA/R&D/Process development for biopharmaceutical applications;
- Extensive polymer chemistry and analysis/characterization knowledge and experiences for medical device or pharmaceutical/biopharmaceutical.
- Knowledge of biopharmaceutical processing, such as upstream, filtration, UF/DF, Chromatography, formulation, single-use technology, and the relevant validation.
- Knowledge of cGMP’s and other worldwide regulatory requirements. BPSA, PDA, BPOG, GMP, USP, FDA, ICH, EP, JP, ISO, REACH, ISPE and ASTM Standard.


Job Segments: Medical, Developer, Materials Science, Pharmaceutical, Law, Healthcare, Technology, Science, Legal
该单位 HR 近两周的应聘简历处理率: 41%

联系人: Zhang Fan

地    址:北京市经济技术开发区永昌北路1号

GE 医疗集团隶属于GE(通用电气)公司,为全世界提供开创医疗护理新时代的革新性医疗技术和服务。GE医疗集团在医学成像、信息技术、医疗诊断、患者监护系统、药物研发、生物制药技术、卓越运营和整体运营解决方案等领域拥有广泛的专业技术,能够帮助客户以更低的成本为全世界更多的人提供更优质的服务。GE医疗集团还和医疗行业领袖加强合作,全力支持全球政策的发展,助力打造成功的、可持续的医疗体系。

GE医疗集团总部设在英国,员工分布于全球100 多个国家和地区,致力于为医疗专业人士和患者服务。

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