Documentation Specialist
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| Job Type | Contractor |
| Location | Dublin |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 2506 |
| Job Views | 25 |
- Description
- Documentation Specialist – Team Horizon
We are seeking applications for an experienced Documentation Specialist (6-month contract) for our client, who are a leading biopharmaceutical company. In this role you will be responsible for providing oversight of all controlled documents that progress through Vault Quality (eDMS). Operating within the Central Quality Systems and Compliance team to support the administration of Document Control through coordination, status tracking and archival of GxP documentation.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
What you will be doing:
Oversight of the eDMS and day to day management of GxP Document Coordination in Vault Quality.
Provide support between Documentation Services and Training to ensure updated documents are highlighted to users and routed as appropriate.
Act as point of contact for all Vault Quality queries.
Provide assistant to BPOs in updating administrative updates to documents that come due for Periodic Review.
To investigate any Document Control or Training related deviations
The management and coordination of the e-Room used to communicate key documents to CMO’s as required.
To work with external and internal stakeholders on the development of Vault Quality and related e-Systems going forward.
Provide support for inspection readiness activities, during health authority inspections.
Provide assistance, where necessary in the issuing and tracking of Periodic Review tasks.
What you need to apply:
Third level qualification e.g. BSc. In science/pharmacy
Minimum of 3 years’ experience in a cGMP Quality environment, or equivalent combination of education and experience
Document Management experience
SOP Authoring, with review and approval experience
Knowledge of GMP
Experience in the use of eDMS and deviation management systems
Excellent MS Word and Excel Skills
Ability to work as part of a team and independently
Proven communication skills including communications to higher level management
