On behalf of my client, a global pharmaceutical company with offices in Dublin, we are collaborating with them on a new vacancy for a Quality System Specialist (Deviations and CAPAs).
This is a hybrid role with approx 2-3 days per week in the Dublin City office.
The primary purpose of this position is the management of the Quality System functions in the organisation in relation to Deviations and CAPAs.
This role will also support with the following systems: Documentation, Change Controls and Training with an overall aspect of risk management process activities incorporated therein.
This job will involve working on a manual and electronic Quality Management System including aspects of an electronic system administration activities.
Your role:Reporting to the Quality System and Digital Transformation Director, you will have the following responsibilities:
Support organisation in management of a Deviation system.Facilitating cross functional meetings and providing guidance and consultation to deviation stakeholders.Collaborating with other departments on completion of investigations and root cause analysis.Supporting in establishment and implementation of effective corrective/preventative actions.Support organisation in management of a CAPA system.Management of CAPAs that derive from various processes: deviations, internal audits etc.Facilitating cross functional meetings and providing guidance and consultation to CAPA owners.Collaborating with other departments on completion of CAPAs.Qualifications & Experience:Pharmacist or Engineer with master's degree in quality, Regulatory or scientific topic.A minimum of 2 + years of experience in pharmaceutical or biotechnology industries.
Relevant experience in either 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 and 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 to make decisions in GXP environment.Excellent interpersonal, written, and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning to be responsive, gain trust and build strategic relationships.Ability to work in an international matrix environment.Fluent English skills required, French or other languages will be a plus.For full details and job spec, email your CV to ****** or call Linda at +353 1 2784703.
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