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 : [email protected]
Profile of the Role:
Responsible for Electronic Documentation and Records Management and also responsible for Execution, Maintenance, and Administration of Document Management Systems.
Description of Duties:
· 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:
o Document management including metadata
o Revision and Change control
o Quality Systems support
o Audit support
o Records Management
Also:
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 ***
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 [email protected]