- Location
- Limerick, IE
- Type
- Full-time
- Closing date
- Today
- Source
- iCIMS
Description
Overview
The primary function of this role is to ensure regulatory adherence of Cook Medicals document control process.
Find out more about Cook Medical here
Responsibilities
- 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.
Qualifications
- 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.
Skills
AgileGMPProject Management