Document Control Specialist

Cook Medical Incorporated; Limerick; On-site; EUR 35,000 - 55,000; Full time

Job summary

Cook Medical Incorporated in Ireland is seeking a Change Analyst focused on regulatory adherence of the document control process within the QA/QMS framework. The role covers GMP/GDP review of change orders, maintenance of the document log, and distribution of quality system documents.

The position includes updating global product files, BOMs, and GPFs for non-Ireland products, plus supporting internal and external audits and training on procedures.

Qualifications

• Cert/Diploma in Quality-related discipline desirable.
• Excellent PC skills, particularly Microsoft Office.
• Previous experience in a Quality environment would be advantageous.
• Self-starter with motivation to learn all aspects of the role.
• Ability to work independently and as part of a team.
• Strong organizational and communication skills.

Responsibilities

• Change Analyst within PLM system.
• Processing and GMP/GDP review of Change Orders.
• Ensure Change Orders are implemented fully.
• Maintain, control and distribute Quality System documentation.
• Obsolete and distribute Quality Management System documents.
• Maintain and control the Document log.
• Generate and distribute data on document system effectiveness.
• GPF updates and maintenance for non-Ireland product.
• BOM updates and supply chain updates for non-Ireland product.
• IFU/PFI File Management updates.
• Implement Global Document Control processes and systems.
• Maintain Quality Systems records.
• Participate in Internal Audits and support External Audits as needed.
• Provide training on Quality System procedures.
• Lead and drive assigned Process Improvements in Document Control.
• Ensure Cook’s Code of Conduct is followed.

Skills

Attention to detail

Interpersonal communication

Independent work

Team collaboration

Project management (desirable)

Organizational skills

Travel willingness

Strong IT skills

Education

Quality-related Cert/ Diploma (desirable)

Tools

Microsoft Office

Job 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.