Job Title: Quality System Specialist (Deviations and CAPAs)
We are seeking a highly skilled Quality System Specialist to join our team at {company}, a global pharmaceutical company with offices in Dublin. This is a hybrid role requiring 2-3 days per week in the Dublin City office.
About the Role:
* Manage the Quality System functions in the organisation related to Deviations and CAPAs.
* Support Documentation, Change Controls, and Training systems, incorporating risk management process activities.
* Work on a manual and electronic Quality Management System, including electronic system administration activities.
Your Responsibilities:
1. Support the organisation in managing a Deviation system.
2. Facilitate cross-functional meetings and provide guidance and consultation to deviation stakeholders.
3. Collaborate with other departments on completion of investigations and root cause analysis.
4. Support the establishment and implementation of effective corrective/preventative actions.
5. Support the organisation in managing a CAPA system.
6. Manage CAPAs derived from various processes: deviations, internal audits, etc.
7. Facilitate cross-functional meetings and provide guidance and consultation to CAPA owners.
8. Collaborate with other departments on completion of CAPAs.
Requirements:
* Pharmacist or Engineer with a master's degree in quality, Regulatory, or scientific topic.
* A minimum of 2+ years of experience in pharmaceutical or biotechnology industries, relevant experience in quality, regulatory, manufacturing, or development.
* Understanding of GxPs, quality systems, and regulations (EU, FDA, ICH).
* Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required.
* Experience with Quality Management Systems heavily preferred.
* Ability to perform independent work requiring attention to detail, accuracy, and scientific judgment.
* Aptitude to comprehend, analyse, and interpret process and systems information, technical procedures, reports, and regulations.
* Excellent interpersonal, written, and oral communication skills.
* Ability to work in an international matrix environment.
* Fluent English skills required; French or other languages will be a plus.