About Us

GxP Quality Systems is an Irish company with over 20 years experience in providing GxP training, auditing and consultancy services to the healthcare sectors. We assist companies achieve continuous compliance with US and EU Good Practice Regulations (GxP) such as Good Manufacturing Practices (GMP & cGMP).

Our personnel have technical qualifications and extensive experience in the implementation of GxP regulations

  • QA / Quality Management Systems
  • QC & R&D laboratories
  • Validation
  • Storage & Distribution
  • Sales & Marketing
  • Regulatory Affairs

We keep up-to-date with regulatory developments to ensure that we can assist our clients with patient protection & regulatory compliance.

Director: Gemma O’Dwyer BSc, MSc, MIITD, IRCA

IRCAGemma is a Microbiologist and has worked in QC, QA and Technical Services in companies manufacturing Active Pharmaceutical Ingredients (APIs), finished pharmaceuticals  and sterile medical devices. Gemma has worked as a Production Manager in aseptic processing and has lectured in Microbiology & Health Care Technology at the Dublin Institute of Technology (DIT). Gemma is an accredited quality systems auditor with the International Register of Certified Auditors (IRCA) and a member of the Irish Institute of Training & Development (IITD).

The company also has available a number of highly qualified and experienced associates and is involved in strategic alliances with other technical experts and consultancies in order to offer our clients a range of expertise.

McDonnell Management