We are collaborating with a global pharmaceutical company based in Dublin on a new vacancy for a Quality System Specialist (Deviations and CAPAs). This hybrid role involves 2-3 days per week at the Dublin City office.
Job Purpose
The primary purpose of this position is to manage the Quality System functions in the organisation related to Deviations and CAPAs.
This role will also support systems including Documentation, Change Controls, and Training with an overall aspect of risk management process activities. It involves working on a manual and electronic Quality Management System, including aspects of electronic system administration.
Your Role
* Support the organisation in managing a Deviation system.
* Facilitate cross-functional meetings and provide guidance and consultation to deviation stakeholders.
* Collaborate with other departments on completing investigations and root cause analysis.
* Support the establishment and implementation of effective corrective/preventative actions.
* Support the organisation in managing a CAPA system.
* Manage CAPAs that derive from various processes: deviations, internal audits etc.
* Facilitate cross-functional meetings and provide guidance and consultation to CAPA owners.
* Collaborate with other departments on completing CAPAs.
Qualifications & Experience
We are looking for a Pharmacist or Engineer with a master's degree in quality, Regulatory or scientific topic. The ideal candidate will have:
* A minimum of 2+ years of experience in the pharmaceutical or biotechnology industries.
* Relevant experience in either quality, regulatory, manufacturing, or development.
* An understanding of GxPs, quality systems and regulations (EU, FDA, ICH).
* Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint.
* Experience with Quality Management Systems.
Key Skills
The ideal candidate will possess:
* The ability to perform independent work requiring attention to detail, accuracy and scientific judgment.
* A consistent record of shifting thought processes quickly from one task to another.
* Aptitude to comprehend, analyse and interpret process and systems information, technical procedures, reports, and regulations.
* Excellent interpersonal, written, and oral communication skills.
* The ability to work in an international matrix environment.
Estimated Salary
$80,000 - $110,000 per annum.