Validation Project Manager / 6 months /
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Medical Devices organisation, based in Noord-Brabant Netherlands.
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?
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’.
• 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.
• 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
The Company
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!
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
