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Validation Project Manager / 6 months /

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The company

Our client is a professional Pharmaceutical and Medical Devices organisation, based in Noord-Brabant Netherlands. Our client is a leading provider of health technology that focuses on improving people's health and achieving better healthcare outcomes throughout the health continuum, from healthy living and prevention to diagnostics, treatment and home care.

Our client uses advanced technologies and in-depth insight into clinical applications and the needs of consumers to develop integrated solutions. The company is a market leader in diagnostic imaging, image-driven treatments, medical IT applications, patient monitoring, home care systems and consumer health applications.

They are looking for a Validation Project Manager. Are you the one?

Role description

In this role, you have the opportunity to...

Be part of a fast-growing business that help improve the lives of millions of people, while advancing our client digital transformation journey as a global leader in Health Technology. You will help reach our client ‘quadruple aim’: enhancing the patient experience, improving health outcomes, lowering the cost of care, and improving the work life of care providers. Cardiology Informatics develops software solutions which are at the heart of our client innovative ambition and ‘quadruple aim’.

Responsibilities

Your responsibilities are:

• Manage several software validation activities in parallel.
• Work with team of process, IT, software validation experts to fix validation gaps. You will be managing the team, resources, planning, progress reporting.
• Interpret standards and regulations and reflect these it the organizations Quality Management System (QMS)
• Perform regular maintenance activities on the Quality Management system.
• Define, develop and provide training against QMS
• Maintain oversight and manage QMS changes needed.
• Create Quality & Regulatory / QMS change management project plans and drive these to completion
• Participate in and advice cross-functional project teams on application of the QMS, taking into account applicable regulations, requirements and standards.
• Review (development) quality reports and plans to ensure they comply with the requirements of the QMS.

Requirements

To be successful in this job you need:

• Gamp5 experience
• Experience in Philips validation processes is pré
• Experience in IT development/maintenance processes
• Experience in executive reporting
• Knowledge of MS Projects, PMP project management
• Experience in Software Validation for Medical Devices
• Strong Experience in project management, stakeholder management, scope management, planning

Other information

This project start from 01/06/2019 to 31/12/2019. So don't wait to long and apply!

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Diana Prieto Reyes.


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SIRE Life Sciences®

Ref. number: 47577
Listed by: SIRE Life Sciences®
Listed on: 09-05-2019
Country: The Netherlands
Region: Noord-Brabant
Employment: Freelance
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Medical Devices
Specialisation: Engineering & Maintenance

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