Senior Template Control Leader
GE Healthcare Bio-Sciences AB / Kemiingenjörsjobb / Uppsala
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hela Sverige Role Summary:
Global Qualification Services delivers documentation and services to global customers which are used for registration of GxP processes and products and research / development / hospital / university.
Essential Responsibilities:
The demand for products and services from Qualification Services is increasing double digits year over year and business segment are added to the portfolio on a yealy basis. As a result of an increasing demand of new qualification products we are seeking an Senior Template Control Leader to help drive and lead the work of the Project Office Business. The role is including the need to cooperate with stakeholders across LS multiple functional teams and regions. The business is pointed to several different LS segments.
Interact with QS Operation, Template Management and NPI/CBS/CCP sub business
Manage and control all Technical review and approval in Template and Order/Production phase
Manage template control for all FlexFactory, CBS, NPI and standard qualification offering
Manage all customer complaints to secure Corrective and Preventive action
Communicate current state to senior management and make sure deliverables are met
Manage all customer complaints (using the tools at hand); handle Quality tasks, regional communication to display CAPA actions completed and in progress
Cooperate and communicate with key stakeholders to secure Qualification Services product development
Lead, improve and manage new product introduction within process/team
Managing quality objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives
Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones
Support communication to wider service organisation on program/project awareness including inputs and involvement in all NPI programs
Qualifications/Requirements:
Ability to communicate with different stakeholders in different regions
Bachelor's degree in Science, Engineering or related area with relevant work experience
Work experience within GxP qualifications within Technical area
Demonstrated knowledge and experience working with technical writing area
Demonstrated capability of cross-functional and cross-site interactions and ability to drive project plans to completion
Ability to develop and execute multiple priorities and approaches to meet objectives
Desired Characteristics:
Experience with entire template development and maintenance flow, procedure and tools
Familiarity with ISO, GxP and other regulatory standards
English and Swedish as working languages
Experience of working in a global environment
Publiceringsdatum2019-02-08Så ansöker duSista dag att ansöka är 2019-02-28
Klicka på denna länk för att göra din ansökanFöretagGE Healthcare Bio-Sciences AB
KontorsadressBjörkgatan 30
Jobbnummer 4602464
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