Job Description
The purpose of this Sr. Spclst, Quality Assurance role is to work within and support the Global Development Quality Assurance team at the Research & Development Division facility in Dunboyne. This role will provide support to the Associate Director QA Systems and Compliance by leading the deployment and maintenance of the QMS, and associated Systems, leading Quality Council required meetings at the Dunboyne facility, and supporting colleagues with Quality Risk Management & Auditing. The role will also act as a mentor and support for more junior team members across QA.
The QA Systems and Compliance Team will work closely with the Operations, Engineering, Validation, Supply Chain and AR & D Functions to ensure compliance to Global and Regulatory Quality Management System requirements as they pertain to the Quality Manual, Change Control, Deviation Management, Supplier Quality Management, Quality Risk Management, Audit Management and associated electronic systems.
Bring energy, knowledge, innovation to carry out the following:
* Manage and oversee the site QMS.
* Ensure compliance with QMS requirements and procedures.
* Initiate and maintain Quality related metrics related to QMS, ensuring effective communication and follow up of same.
* Ensure a documentation system is in place and is compliant with requirements.
* Review and approve documents as defined by QMS requirements.
* Ensure there is a change management system to assess the impact of changes on product, validated process, test methods, specifications, regulatory filing and GMP documents.
* Ensure there is a Deviation Management system to document and investigate unplanned events and effective CAPA for same.
* Ensure there is a process and system for management of approved suppliers at site.
* Coordinate the Site Quality Council activities.
* Implement any changes to the Quality Management System at the site.
* Provide quality support to the project and site, including training and guidance on the interpretation and implementation of Guidelines / Policies and regulatory requirements.
* Represent the site’s Quality Management System during GMP inspections.
* Lead training of staff to assure appropriate level of compliance across all areas.
* Support maintenance and continuous improvement of quality management systems and associated documentation.
* Participate in Communities of Practice for Quality Systems owned QMS topics.
* Participate in walkthrough audits and Permanent Inspection Readiness.
* Develop, maintain & report relevant metrics to site and above site functions.
* Support colleagues for Quality Risk Management, Internal and External Auditing and Permanent Inspection Readiness.
* Work collaboratively to drive a safe and compliant culture.
* Ensure the escalation of compliance risks to management in a timely manner.
* Additional activities as assigned by the manager/supervisor.
What skills you will need:
In order to excel in this role, you will more than likely have:
* Degree qualification (Science/Quality/Technical).
* Minimum 6 years experience, ideally in Quality Control / Manufacturing / Technical Operations and Quality Assurance.
* Thorough understanding of major Health Authority Guidelines and Regulations.
* Working knowledge of Quality Control, Manufacturing and Supplier processes to apply to performing internal Audits.
* Experience in Health Authority Inspections.
* Ability to think logically and be proactive under pressure or when the path forward is uncertain.
* Ability to work as part of a team and on own initiative in a constructive manner.
* Flexible and self-motivated.
This role is a hybrid role, with a minimum requirement for 3 days per week onsite.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Employee Status: Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements: Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date: 04/28/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R344503
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