Helen Atkinson

Biography

Helen Atkinson has been working as a Senior Consultant with SeerPharma Pty Ltd for the past 9 years providing quality and GMP consulting to the life sciences industry. Prior to moving to Australia she was employed by Abbott Laboratories in a number of roles within QC and later Manufacturing, Science and Technology in the UK. Helen is experienced in all stages of Human and Veterinary therapeutic product manufacture according to relevant current codes of GMP. Significant recent product experience includes aseptic and terminally sterilised products, radiopharmaceuticals and complementary medicines. Helen has held roles in Senior Quality Management positions redesigning and implementing quality systems to meet current regulatory requirements for both local and overseas inspectorates. She has successfully prepared, managed and closed out inspections from FDA, TGA and APVMA on behalf of clients, and presented sterile manufacturing and validation plans to international regulators. Helen is also experienced in implementation of CAPA, Deviation, OOS systems and development of Quality Metrics to ensure continuous improvement. Helen has provided GMP and validation expertise to new facility design and build projects, including preparation and implementation of Validation Master Plans to meet both TGA and FDA requirements.

Research Interest

BSC (Hons) in Biomedical Chemistry