Freelance SAP QMS Consultant
Location: NetherlandsSIRE 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 COMPANY
Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.
You will focus on delivery of validated projects.
ROLE DESCRIPTION
The Freelance SAP QMS Consultant plays a vital role within the organisation in order to deliver validated projects within a large Quality Management Systems program. You will control the process during the entire project life cycle, starting at the development, until implementation, change controls and disentanglement. Furthermore will you validate all associated applications which are delivered by the project teams in order to guarantee compliancy according to the FDA / ISO standards.
RESPONSIBILITIES
- Guarantee validation procedures of IT applications and interfacing to the QMS
- Change control during new implementations and disentanglement of QMS
- Development of a new validation strategy
- Represent several business units during external audits
- Provide Software QA solutions during implementation and development of new QMS applications
- Compliancy according to FDA and ISO13485
- Collaboration with validation engineers
- Development of user manuals and technical documentation for all IT systems
- Training of end-users and management team in order to increase compliancy
REQUIREMENTS
- 5+ years’ experience in Software QA / Validation
- 10+ years’ experience in Software Life Cycle Process Development
- Experience with SAP migration projects
- Knowledge of SAP QMS and/or SAP HANA is a strong asset
- Previous experience with 21 CFR Part 11, ISO13485, GAMP and/or CSV
- Expert in validation, data security and data life cycle management
- Previous experience with audits of notified bodies
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Hayo Gerbranda.
