Documentation Coordinator

ref. 00863

Documentation Coordinator  

Join our client, a world class biologics manufacturing facility based in Co. Louth.

Manage the company’s electronic & hardcopy documentation management system in preparation for handover from the Project Team to Engineering for sustaining operations. This role will support the Engineering Department and report directly into the Plant Engineering Lead.

As an integral part of the Engineering team, you will be responsible for developing standard documentation methods and procedures for efficient management of Engineering Documentation.

Responsibilities

Management and organize documentation from the project team, sort and file in paper and electronic format
Follow and uphold EDMS Standards and Procedures.
Ensure that all change management updates are captured and reflected on the appropriate documentation.
Ensure that documentation issued from projects are correct and are in line with site standards.
Ensure compliance for all standards and procedures that fall under the responsibility of the organisation.
Ensure all documentation are stored correctly in electronic and paper format
Work closely with Engineering Project Teams to manage handover efficiently
Ensure all activities are carried out in line with Company policy. Play an active role in the Documentation standards inputs.

Requirements

2+ years in data management/admin related role.
Previous experience in the pharmaceutical or biotech industry will be highly advantageous
Experience using EDMS such as Viewpoint, SAP, Google Sheets etc.
Experience in a start-up or commissioning facility would be beneficial
Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation.
Interact with above site personnel to understand changes and promote the site.