Marie O’Callaghan holds a master’s degree in inorganic chemistry from University College Galway. She started her career as a QC chemist in an API site, gaining valuable experience with many analytical techniques. She then spent seven years working in an R&D environment for inhalation products, spanning analytical method development and validation, equipment validation, supplier management, supplier auditing, specification development, and regulatory affairs. This was followed by a number of years working directly in regulatory affairs, managing the regulatory processes in EU and ROW jurisdictions for several different formulations, including gels, liquids, ointments, suppositories and capsules. Ms. O’Callaghan held a number of senior roles within quality, gaining experience with biologics and aseptic manufacture. She hosted regulatory audits from the HPRA, the U.S. FDA and ANVISA, as well as supporting and presenting during audits by Russia, China and corporate. She is eligible to act as a QP and has six years’ experience as a QP for sterile products.
Recognized Expertise Includes:
- Change control
- Quality management systems
- GMP auditing of facilities and processes
- Sterile manufacture of biotech products
- Supplier management