Senior Validation Specialist/Manager

面议 上海 经验不限 学历不限 全职
GE通用电气(中国)医疗集团 2017-08-22 更新 2017-11-11 截止

Senior Validation Specialist/Manager


Role Summary/Purpose: Responsible for building up and leading GE lifesciences validation services in China for China market to support Chinaoverall bioprocessing business growth. This role is the expert in singleuse validation, bioprocessing systems and consumables validation, andpotentially the leader to build up and mange GE validation services tooffer GE as a total solution provider.
Essential Responsibilities:
- Work closely with commercial team and biopharmaceutical end users, tounderstand and identify the important areas of validation required toserve the market needs.

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

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

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

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

- Initial responsible for developing and improvingextractables/leachables documentation and testing; Write and reviseprotocols, procedures, reports and other documentation as necessary tosupport the customer; Identify critical process parameters andconducting experimental analyses; Utilize scientific principles andexperience to independently execute and optimize experiments in theprocess of validation; Work with internal associates and externalexperts to manage the challenges including unexpected experimentaldifficulties, technical hurdles, trouble shooting and conflicts withintest project; Cooperate and communicate with project coordinator toensure project progress.

- Deliver validation trainings to customers and speeches during keyevents and conferences.

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

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

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

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

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

- Responsible for developing and improving extractable documentation andtesting; Write and revise protocols, procedures, reports and otherdocumentation as necessary to support the customer; Identify criticalprocess parameters and conducting experimental analyses; Utilizescientific principles and experience to independently execute andoptimize experiments in the process of validation; Work with internalassociates and external experts to manage the challenges includingunexpected experimental difficulties, technical hurdles, troubleshooting and conflicts within test project; Cooperate and communicatewith project coordinator to ensure project progress.
- Problem solving ability and excellent oral and written Englishcommunications skills

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

- 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 invalidation/services/QA/RA/R&D/Process development forbiopharmaceutical applications;
- Extensive polymer chemistry and analysis/characterization knowledgeand 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 ASTMStandard.

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