Quality Admin/Document Controller Galway

Posted: 11th December, 2024

Title: Quality Admin/Document Controller

Department: Manufacturing

Location: Galway, Ireland

 

Purpose

The Quality Admin/Document Controller will play a crucial role in supporting the Quality Management team by ensuring the accurate management, organization, and control of all quality-related documentation. This role is essential to maintaining compliance with industry standards, facilitating effective communication, and ensuring the integrity of our quality management system (QMS).

Responsibilities

Document Control:

• Manage and maintain the document control system, including the creation, review, distribution, and archiving of quality documentation.
• Ensure all quality documents (e.g., procedures, work instructions, forms, and records) are up-to-date, properly formatted, and adhere to company and industry standards.
• Control the issuance of documents, ensuring that only the latest revisions are available to relevant stakeholders.

Quality Management System (QMS) Support:

• Assist in the development, implementation, and maintenance of the QMS per ISO13485.
• Monitor compliance with the QMS, identifying areas for improvement and assisting with corrective and preventive actions (CAPA).
• Support internal and external audits by providing necessary documentation and information.

Reporting and Analysis:

• Generate regular and ad-hoc reports on document control activities, quality performance, and compliance metrics.
• Assist in the analysis of quality data to identify trends and support continuous improvement initiatives.

Communication and Coordination:

• Serve as the primary point of contact for document control inquiries and requests, ensuring timely and effective communication.
• Coordinate with various departments to ensure the consistent application of quality standards and procedures across the organization.
• Provide administrative support to the Quality Management team, including scheduling meetings, preparing agendas, and recording minutes.

Training and Support:

• Provide training and guidance to staff on document control procedures and the use of the QMS.
• Assist in the onboarding of new employees by ensuring they are familiar with the relevant quality documentation and procedures.

Reporting and Analysis:

• Generate regular and ad-hoc reports on document control activities, quality performance, and compliance metrics.
• Assist in the analysis of quality data to identify trends and support continuous improvement initiatives.

 Other assigned duties

• Arrange Environmental tasks in the cleanrooms with an external contractor
• Complete internal Environmental testing as required (Particle Counts)

Education and / or Experience:

Education in Quality Preferred (Level 6) 1+ years’ experience in quality or related discipline preferred

The successful candidate will possess the following key attributes:

• Must have excellent MS Excel skills and be proficient in Microsoft Office
• Strong attention to detail
• Strong verbal and written communications skills.
• Excellent attendance record.
• Understanding/awareness of Customer requirements in terms of quality and delivery.
• Ability to impart knowledge in clear concise manner.
• Demonstrate working as part of a team with common goals.
• Decision-making and Reporting skills

The above list of job responsibilities is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post.

FOR INTERESTED APPLICANTS: If you are interested in this position, please send a brief cover letter, resume, please state the job title applying for and any other relevant material for the candidacy to GalwayHR@nelipak.com. Thank you!

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