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Quality Systems Specialist - **NEW**

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Neg
Start date
4 Jun 2024
Closing date
4 Jul 2024

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Discipline
Quality, Systems Manager
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

                                                                                                                 

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)

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 tdunne@thornshaw.com or call Tina at +353 1 2784701.   Thornshaw Scientific is a division of the CPL Group www.thornshaw.com

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

thornshaw-ourmission

For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

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