Role DescriptionWe are looking for an enthusiastic contingent worker in the area of Change, Document and Record control with experience in Business / Quality Management Systems (ISO 9001 / ISO 13485) and FDA (21 CFR) regulations in an international environment.
ResponsibilitiesYou will be a member of the support group of the Document & Record management system. In your role you will: • Support lower level Document Control Specialists. • Controls & maintains the document management system for issuance recording / filing, tracking, retrieval of documents like procedures, plans, QA/QC records, Specifications and related documents. • Leads and supports (local) authors of controlled documents to be lean, accessible, easy to maintain and according to the agreed look and feel.
KEY AREAS OF RESPONSIBILITIES • Effective (local) Business Process Ownership/Expert role for Document Control processes and tools in scope • Establish Document Control support to authors and (local) process owners in defining and producing lean Quality System documents and records; ensure proper quality of the content of documentation and records • Establish and manage proper document review processes • Ensures availability/publishing of controlled documents • Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business
Requirements- must have items: • 3 to 5 years related experience in change control and/or document control field • Familiarity with Document Management System tools • Experience running effective process improvement projects • Knowledge of FDA regulations and regulatory requirements • Preferred Qualifications: o Engineering background. o Prior group or team leadership experience. o Procedural or Technical writing experience. o Understanding of modeling tools. o Awareness of Project Management Institute standards.
Required competences: • Knowledge about Quality Management, Regulatory Management • Being a Q&R Business Partner • Able to support Computer Systems Validation • Able to work in a virtual environment • Advanced MS Office user (inclusive SharePoint Designer)
- nice to have items • Procedural or Technical writing experience. • Understanding of modeling tools. • Awareness of Project Management Institute standards.
Other informationWe are looking for a candidate for a support role with preferably a technical back ground or a Q&R back ground with knowledge of IT. A technical background in a regulated environment and understanding of the functional setup / configuration of IT tools would be perfect. You will be helping the team with 3rd line support.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.