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:
1. Manages and oversees the site QMS.
2. Ensures compliance with QMS requirements and procedures.
3. Initiates and maintains Quality related metrics related to QMS, ensuring effective communication and follow up of same.
4. Ensures a documentation system is in place and is compliant with requirements.
5. Reviews and approves documents as defined by QMS requirements.
6. Ensures there is a change management system to assess the impact of changes on product, validated process, test methods, specifications, regulatory filing and GMP documents.
7. Ensures there is a Deviation Management system to document and investigate unplanned events and effective CAPA for same.
8. Ensures there is a process and system for management of approved suppliers at site.
9. Coordinates the Site Quality Council activities.
10. Implements any changes to the Quality Management System at the site.
11. Provides quality support to the project and site, including training and guidance on the interpretation and implementation of Guidelines / Policies and regulatory requirements.
12. Represents the site’s Quality Management System during GMP inspections.
13. Leads training of staff to assure appropriate level of compliance across all areas.
14. Supports maintenance and continuous improvement of quality management systems and associated documentation.
15. Participates in Communities of Practice for Quality Systems owned QMS topics.
16. Participates in walkthrough audits and Permanent Inspection Readiness.
17. Develops, maintains & reports relevant metrics to site and above site functions.
18. Supports colleagues for Quality Risk Management, Internal and External Auditing and Permanent Inspection Readiness.
19. Works collaboratively to drive a safe and compliant culture.
20. Ensures the escalation of compliance risks to management in a timely manner.
21. 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:
1. Degree qualification (Science/Quality/Technical).
2. Minimum 6 years experience, ideally in Quality Control / Manufacturing / Technical Operations and Quality Assurance.
3. Thorough understanding of major Health Authority Guidelines and Regulations.
4. Working knowledge of Quality Control, Manufacturing and Supplier processes to apply to performing internal Audits.
5. Experience in Health Authority Inspections.
6. Ability to think logically and be proactive under pressure or when the path forward is uncertain.
7. Ability to work as part of a team and on own initiative in a constructive manner.
8. 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.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
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