Philips is 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 (21CFR) regulations in an international environment. The Document Control Specialist will be a member of the support group of the Philips Document & Record management system.
- In the role of a Document Control Specialist, you will control and maintain the document management system for issuance recording / filing, tracking, retrieval of documents such as procedures, plans, QA/QC records, specifications and related documents.
- You will lead and support (local) authors of controlled documents to be lean, accessible, easy to maintain and according to the agreed look and feel.
- It will be your responsibility to establish Document Control support to authors and (local) process owners in defining and producing lean Quality System documents and records. Thereby, you will ensure proper quality of the content of documentation and records.
- The Document Control Specialist will establish and manage proper document review processes, and ensures availability/publishing of controlled documents.
- You will establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business.
To succeed in this role, you should have the following requirements:
- 3-5 years related experience in change control and/or document control field.
- Familiar with Document Management System tools and experience in running effective process improvement projects.
- Acquired knowledge of FDA regulations, regulatory requirements and quality management.
- Therefore, you have experience in team leadership, procedural/ or technical writing and engineering.
- You are aware of Project Management Institute standards.
- You can behave as a Q&R Business Partner.
- Ability to support Computer Systems Validation and to work in a virtual environment.
- Advanced MS Office user (inclusive SharePoint Designer).