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SENIOR QA AUDITOR

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Start date
5 May 2021
Closing date
4 Jun 2021

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Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

My client, a global company with European Headquarters based in Dublin have a new opportunity for a Senior QA Auditor.

You will be part of a dynamic team.  The Quality Assurance team provides support to all sides of their business. Working on complex QA matters across the business, the QA team delivers on projects internally and externally.

The Role

  • Leading on external audits and inspections including scheduling, preparation, and hosting.
  • Supporting inspection readiness activities, including inspections of external sites.
  • To lead CAPA management for external audits and regulatory inspections where needed, in order to assure responses are compliant with SOP requirements, Good Clinical Practice guidelines and relevant regulations, including ensuring appropriate corrective and preventative actions are put in place and CAPAs are followed until resolution.
  • Preparing root cause analysis on quality issues including ensuring appropriate root cause analysis, implementation of corrective and preventative actions and follow-up and effectiveness of resulting CAPAs.
  • Manage inspection readiness activities.
  • Lead CAPA management for inspection, where needed, including ensuring any Inspection CAPA commitments are tracked and followed until resolution.
  • Identify and track required effectiveness checks and ensure effectiveness checks are completed within the require timelines.

This role will include post COVID travel of up to 35%.

What you need

  • Background in medicine, science and/or other relevant discipline and appropriate experience.
  • Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials.
  • Experience in hosting external audits and/or regulatory inspections
  • Knowledge of CAPA management, including performing effective root cause analysis
  • Experience in regulatory authority inspections an advantage
  • Knowledge of medical Device (MDDR) an advantage
  • Ability to review and evaluate clinical data / records.
  • Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators, and clients.
  • Detailed understanding of drug development and clinical trial process.
  • Good problem resolution skills.
  • Good planning and organizational skills with the ability to multi-task and prioritize effectively.
  • Ability to work efficiently and independently under pressure.

Show job spec on request. 

For full details call Tina at +353 1 2784701 or email your CV to tdunne@thornshaw.com

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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