Document Controller Quality

3 weeks ago

Limerick, Ireland Kenny-Whelan & Associates Full time

Overview
Document Controller Quality
On behalf of its Client, Kenny-Whelan are hiring a Document Controller Quality, for one of its Global Life Sciences Companies in Limerick.
Contact: Carmel Synnott :
******
Responsibilities
Responsible for Electronic Documentation and Records Management and also responsible for Execution, Maintenance, and Administration of Document Management Systems.
The Document Controller will aid in initial program start-up and routine operation of the site, as well as support site inspection readiness and execution.
The Document Controller will aid in start-up and routine operation of the document and records management program execution in particular:
Document management including metadata
Revision and Change control
Quality Systems support
Audit support
Records Management
Maintain documents and records maintained in the relevant Electronic Management System, ensure that the right content is prioritized and that content is kept up to date over time.
Ensure compliance to Global and Local Documentation and Records Management requirements.
Establish new and modify existing documentation in a manner which will achieve accuracy and avoid errors and product recalls or issues.
Manage the flow of documents from initiation of workflow to approval.
Day to day management and monitoring of assigned workflows.
Review and accept incoming documents are complete and aligned with GDP, support initial review of documentation for end-users.
Ensure that technical documentation is kept up to date with the support of technical team members for the creation of content
Assist administration and generation of regular reporting of document workflows
Meet with cross functional departments to review documents and assign meta data when adding documents into Electronic Management System
Manage Retention of GMP Related Records in accordance with Document Type and Record Class Code.
General admin assistance: monitor review comment backlogs, organize and facilitate large document review meetings etc.
Provide training to appropriate personnel on document control interfaces.
Support Site Self Inspections associated with Document Control & the Electronic Management System.
*** The above is not an exhaustive list of duties ***
Qualifications
Experience and Requirements:
-3 to 4 years' experience as Document Controller with Quality (preferred) experience and in the Pharma/Biotech industry
-Relevant 3rd level business / science qualification
Ability to create prototype implementations to test documentation accuracy and effectiveness preferred but not essential
IT Systems
EDMS experience essential
Ms Office Suite advanced
*** Please note this is an 'Onsite' Role Monday to Friday ***
All applications will be treated with the strictest confidence
Kenny-Whelan Contact:
For further information please, send your updated CV to ******
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