Document Control Specialist

Bedrijfsnaam: -
Plaatsingsdatum: 06/04/2019
Standplaats: -

Functieomschrijving

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands.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 (21CFR) regulations in an international environment.

You will be a member of the support group of the Philips 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.

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)

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Robin Hiariej.

 

Aanbod/arbeidsvoorwaarden
-

Samenvatting

Plaatsingsdatum :
06/04/2019
Referentienummer :
98183
Standplaats :
-
Adres :
-
Postcode :
9723 HK
Opleidingsniveau :
WO
Uren :
Nader te bepalen
Dienstverband :
Vast
Werkervaring :
3 - 5 jaar
Contactgegevens :
bekijk