Document Control Specialist

Ie-Limerickmid

Learning & Development SpecialistPeople

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Overview

Overview The primary function of this role is to ensure regulatory adherence of Cook Medicals document control process.

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Learning & Development SpecialistPeople

The primary function of this role is to ensure regulatory adherence of Cook Medicals document control process.

Find out more about Cook Medical here

~1 min read

→Change Analyst within the Agile Product Lifecycle Management (PLM) system.
→Processing and GMP / GDP review of Change Orders (CO’s).
→Ensure Change Orders are implemented fully.
→Maintenance, control and distribution of Quality System documentation.
→Obsolete and distribute Quality Management System documents.
→Maintenance and control of the Document log.
→Generation and distribution of data on the effectiveness of the Documentation system.
→Global Part Number (GPN) Assignment and CIMS update for non Cook Ireland product.
→Bill of Material (BOM) updates.
→Supply Chain updates for non Cook Ireland product.
→Global Product File (GPF) updates and maintenance of the GPF.
→IFU/PFI File Management updates.
→Implementation of Global Document Control processes and systems as appropriate.
→Management and maintenance of Quality Systems records.
→Participation in Internal Audits if desired.
→Support External Audits where required.
→Provide training on Quality System procedures where required.
→Ability to lead and drive assigned Process Improvements within the Document Control Department essential.
→Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

~1 min read

Cert/Diploma in Quality related discipline desirable.
Excellent PC skills, particularly Microsoft Office.
Previous experience of working in a Quality environment would be advantageous.
A self starter and motivated to learn all aspects of the role.
Ability to work independently but also work well as part of a team.
High attention to detail.
Strong interpersonal skills with the ability to communicate effectively at all organisational levels.
Project Management abilities highly desirable.
Strong organizational skills. Ability to set priorities, develop a work schedule, monitor progress towards goals, and track details/data/information/activities.
Willingness and availability to travel on company business.
Qualified and experienced Quality Auditor desirable but not essential.