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CSV Specialist - Home Based Options

Business Type: Biotechnology Company, Medical Devices Company
Job Type: Medical Devices
Job Level: Experienced (non manager)
Position: Full Time
Salary: EUR35000 - EUR45000 per annum
Location: Czech Republic
Reference: EM/ED/01
Closing Date: 28/05/19
Job Details:

My client is a global leader in their market and, due to company expansion, now needs a CSV specialist to support them on either their Spanish or Czech sites. The role offers great home based opportunities with the need to be in the office for only 2 days a week and also a chance to further develop your skills and career.


Assuring GxP (CSV) computerized systems have been validated to reflect the company''s intended usage of the system.
Work in close partnership with IT and business units to assure computer systems are implemented and maintained in a state of compliance to support business operations.
Responsible for assuring validation of the computer systems and qualification of supporting infrastructure follow appropriate procedures meeting regulatory compliance requirements.
Understanding of current regulatory bodies supporting computerized systems and ensuring all regulations have been met prior to releasing system for production use
Lead small-scope projects and/or elements of large-scope projects, including developing and/or scheduling key milestones, securing and allocating resources, and/or representing quality management on cross-functional teams
Collect and generate metrics, and draw inferences for system improvement opportunities

Required Skills/Education:

University Degree in Engineering, Computer Science, or related discipline
5 years of QA experience (CSV preferred) in medical devices or pharmaceutical industry
Prior experience working in complex business environment
Experience managing complex projects is preferred

Posted: 21/05/2019 | NPJ Ref: 235983
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