Document Controller Quality New

3 weeks ago

Limerick, Ireland CPL Full time

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]

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