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About Sophia Quality Solutions

Sophia Quality Solutions was established by Geraldine Gallagher in 2006 to provide reliable and value added Quality Solutions to the Pharmaceutical, Biotechnology, Medical Device and Cosmetic sectors.

Prior to establishing Sophia Quality Solutions, Geraldine held numerous roles for 17 years in the management of Quality and Regulatory functions with Pharmaceutical, Biotechnology and Medical Device manufacturers in Ireland and in the US.

Geraldine possesses hands on experience with all of the components of a Quality System such as Auditing, Senior Management Reviews, CAPA and Complaints to name but a few.

Geraldine has worked actively as a Qualified Person since 2002 and has experience of the following Product Portfolio:

  • Sterile formulations (ampoules, syringes, vials, bottles, lyophilised and blow fill seal products)
  • Oral formulations (tablets, capsules, suspensions)
  • Ophthalmic formulations
  • Topical formulations (creams, gels, ointments)
  • Drug coated stents

 

Organization Chart

  • Aseptic Processing
  • Quality Management Systems
  • Quality Improvement projects such as Right First Time
  • Auditing against EU GMPs, FDA GMPs, ISO 9001, ISO 13485, ISO 22716 and ISO 14644 standards
  • Batch Record Review and Product Disposition procedures
  • Design of specialised training programs covering GMP and Regulatory topics
  • Lean Six Sigma Problem Solving Methodology

 

Organization Chart

  • B.Sc. (Hons) Microbiology - University College Galway Ireland 1986
  • M.Sc. (Hons) Biotechnology - University College Galway Ireland 1988
  • Registered Assessor Training (ISO 9000 and Quality Auditor) - 1994
  • Diploma in Pharmaceutical Manufacturing Technology - Trinity College Ireland 2000
  • Lean Six Sigma Green Belt  - 2004
  • Train the Trainer - 2007

 

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