Job DescriptionThe Document Control Specialist is responsible for managing document control and change control activities within the Quality Management System (QMS). This role ensures that controlled documents are properly revised, approved, distributed, and archived in the electronic document management system (EDMS). The specialist collaborates with internal teams and external partners, including contract manufacturers, to maintain compliance with quality standards. Additionally, they support audits, regulatory inspections, and various quality system modules, including change control, nonconformance (NC), corrective action (CAPA), and design history files.Job RequirementsSkills: Excellent communication, time management, organization and problem-solving skills; attention to detail, multi-tasking, experience in electronic document management system (EDMS)/ Quality Management System
Experience: 2+ years in a similar role preferred but not required.
Education: Bachelor's degree in related field; Quality certifications a plusJob Responsibilities
* Ensure controlled documents are revised, approved, distributed, and archived in electronic document management system (EDMS).
* Ensure appropriate training is conducted before making documents effective.
* Responsible for formatting of all documents to ensure alignment with company procedures.
* Communicate with internal and external partners (contract manufacturers) throughout document control and change control processes.
* Support change control, nonconformance (NC), corrective action (CAPA), audit, and design history file quality system modules in eQMS.
* Coordinate activities with Therakos document control team to ensure requests are handled in a timely and efficient manner.
* Support during internal audits and regulatory inspections.
Job Benefits
* Competitive salary and benefits package.
* Opportunities for professional development and career growth.
* Collaborative and innovative work environment.
Site/ Primary Work Location: Dublin, Ireland
Primary Work Model : Hybrid (3+ days/week in office)
Disclaimer:
The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.