Debbie Parker
Lead Consultant
About Debbie,
Debbie is an experienced Quality Assurance leader and validation professional with more than 25 years of pharmaceutical and medical device industry experience. She holds a Bachelor of Science (Chemistry) and a postgraduate diploma in Engineering (Industrial Information Technology), with a focus on the validation and implementation of computerised systems.
Her expertise includes quality management systems, equipment and computer systems validation, QC testing, stability and analytical method validation, technical writing, and audit preparation and remediation. Debbie has comprehensive knowledge of GMP, GLP, GCP, PIC/S, 21 CFR Parts 11, 210, 211, 820 and 800, ISO 13485, ISO 14971, ISO 17025, and APVMA, and TGA and FDA regulatory expectations. She has supported organisations ranging from early-stage companies conducting clinical studies to multinational manufacturers producing sterile injectables, oral solid dose, veterinary products, combination products, medical devices, topicals, and sunscreens.
Debbie is recognised for her collaborative approach and her strong analytical and investigative skills, particularly in identifying root causes and developing clear, practical corrective actions. She excels in improving QMS documentation, streamlining processes, removing ambiguity from SOPs, and producing logical, user friendly procedures. Her ability to translate regulatory requirements into workable operational processes is a key strength.
Her broad experience enables her to rapidly understand new environments and apply quality principles in a practical, fit for purpose manner suitable for organisations across Australia and the Asia Pacific region.
