Change Document Controller
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 Pharmaceutical organization, based in Noord-Brabant Netherlands.
ROLE DESCRIPTION
As Document Change Controller you are working in the area of Change, Document and Record control with experience in Business Quality Management Systems (ISO 9001 / ISO 13485) and FDA (21CFR) regulations within an international environment.
RESPONSIBILITIES
- 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
REQUIREMENTS
- BA/BS degree.
- 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
OTHER
The offer will be based on a temporary contract (1 fte) till end of 2018.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.
