Product types and processes with which she is familiar include small molecule APIs, bulk drug substances, medical devices and finished pharmaceuticals and biopharmaceuticals. Dosage forms include lyophilized products, aseptic filling, liquids & tablets, creams, sachets, powders and patches.
Paula Dillion is a senior regulatory consultant with The Compliance Group specialising in the area of controlled drugs and Good Distribution Practice (GDP). Paula worked in the pharmaceutical sector before undertaking a masters degree in Forensic Science. In 2002, Paula joined the IMB as a scientific officer in the area of controlled drugs in licensing function from the transfer of the controlled drugs licensing function from the Department of Health and Children in the IMB. Within this roll she represented Ireland at meetings of the Drug Precursor Committee and Working Group on an EU level. In 2006 Paula was appointed as an inspector and was responsible for conducting both GDP and controlled drugs inspections. During this time Paula represented the IMB at PIC/S GDP Working Group meetings and at the GDP Drafting Group of the EMA, responsible for redrafting thee GDP Guidelines for which she acted as Rapporteur. During her time in the IMB, she was trained as a GMP Inspector for API manufacturing. Paula has worked as the Head of Quality for an Irish based distributor and has been the nominated Responsible Person for two wholesalers. She also holds a Master’s Degree in Industrial Pharmaceutical Science, making her eligible to act as a QP. Paula was also employed as a Quality Assurance Supervisor in an API Manufacturer.