SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
The companyOur client is a professional Medical Devices and Pharmaceutical organization, based in Noord-Brabant Netherlands. Large Medical Devices company.
Role descriptionLooking for Q&R experienced people with practical experience in Medical Devices supporting Design Controls, Procurement, Manufacturin, Marketing, Services, Procurement, and Quality Processes. Also design, production, Software, Clinical, IT processes are important. We do not expect somebody who knows everything about all these areas, but if you are experienced in some areas and if you know a lot about business processes in QA Medical Devices/Pharma, it might be a good fit.
Responsibilities- Quality Management System Business Process Expert, acting in support of the Quality Assurance team and Q&R Business Process Owner, across the Q&R network.
• Participate directly as the Quality Management System Business Process Expert in “Process Capabilities” deployment programs, in the Idea to Market (I2M), Market to Order (M2O), and/or Order to Cash (O2C) arenas. Ensuring compliance, efficiency and effectiveness of the processes within the Healthcare sector, cross sectors, and at Philips corporate.
• This entails a thorough knowledge, as example, of Design (I2M), Marketing & Brand & Promotions (M2O), Production & Servicing (O2C) and Procurement /Purchasing
• Includes, but is not limited to all Idea to Market (I2M), Market to Order (M2O), and/or Order to Cash (O2C) processes.
• Support cross setup and deployment of the Quality Management Systems along business model lines as identified by End to End teams through the creation of Quality Transition Plan(s) that identifies appropriate Q&R activities to ensure compliance.
• Work with End to End & ARIS process modeling teams, Business Management System and Quality Management System owners, as well as any other stakeholders to ensure new process descriptions and procedures (PDDs – Process Definition Documents) are efficient, effective, and compliant to the applicable regulations
• Work with Software validation teams to ensure fully integrated, validated and compliant Integrated Landscape (IL) software application are deployed.
RequirementsEngaging as expected, connecting with team, and delivering reports.
What we don't need: somebody who does not deliver Quality Plans and requires “hand holding” to deliver procedures or to take the initiative to drive them to completion.
Other information- Software Validation experience
- Lot of experience in QA/RA