We are looking for an enthusiastic contingent worker in the area of Change, Document and Record control with experience in Business Quality Management Systems (ISO 13485) and FDA (21CFR) regulations within an international environment?
Leads and supports lower level Document Control Specialists.
Effective (local) Business Process Expert role for Document Control processes and tools in scope.
Establishes Document & Record 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
Leads and supports (global) authors of controlled documents to be lean, well accessible, easy to maintain and according to the agreed look and feel.
Effective (local) Business Process Ownership/Expert role for Document Control processes and tools in scope
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
You are part of the Philips Q&R– PQMS capability and working in the area CL Personal Health Businesses. You will be part of the CL Business Management System team existing of 7 persons dealing with activities like Quality Management, System Validation, Training, CAPA and Change (Document) Control.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. The offer will be based on a temporary contract (1 fte) till end of 2016.
CMII certification (or other equivalent configuration management certification) preferred.
6 Sigma/ LEAN certification preferred.
Minimum of 6 years of related experience in change control and or document control field
Familiarity with Document Management System tools
Experience running effective process improvement projects
Knowledge of Applicable regulations (Quality System Regulations) and regulatory requirements
Strong focus on customer service
o Engineering background.
o Procedural or Technical writing experience.
o Understanding of modeling tools.
o Awareness of Project Management Institute standards.
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