Regulatory Document Control Specialist

Cook Medical Incorporated; Munster; Presencial; EUR 40.000 - 65.000; Jornada completa

Descripción de la vacante

Cook Medical Incorporated in Ireland is seeking a Change Analyst to ensure regulatory adherence of the document control process within the PLM system. The role focuses on GMP/GDP review of Change Orders, implementation of changes, and robust maintenance of Quality System documentation.

You will manage document logs, perform data analysis on system effectiveness, and support internal and external audits. Travel may be required; strong attention to detail and teamwork are essential.

Formación

• 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.

Responsabilidades

• Change Analyst within the Agile PLM system.
• Processing and GMP / GDP review of Change Orders.
• 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.
• 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.

Conocimientos

PC skills

Microsoft Office

Interpersonal skills

Attention to detail

Organizational skills

Communication skills

Project management

Teamwork

Willingness to travel

Educación

Cert/Diploma in Quality related discipline

Quality Auditor qualification desirable

Descripción del empleo

Cook Medical Incorporated in Ireland is seeking a Change Analyst to ensure regulatory adherence of the document control process within the PLM system. The role focuses on GMP/GDP review of Change Orders, implementation of changes, and robust maintenance of Quality System documentation.

You will manage document logs, perform data analysis on system effectiveness, and support internal and external audits. Travel may be required; strong attention to detail and teamwork are essential.