Eliza Rad
Senior Consultant
About Eliza,
Eliza has 20+ years of experience in a variety of GMP compliance roles across the pharmaceutical and medical devices industries. She specializes in providing compliance advise throughout the life cycle of computersied systems within the scope of GxP regulations, with a focus on 21 CFR Part 11, EudraLex / TGA Annex 11 regulations and ISPE GAMP 5 guideline. Her expertise extends to Qualification and Validation programs – including computerised systems – and the establishment and management of an effective Quality System. Her work supports regulatory and compliance approvals for pharmaceutical, complementary medicines, medical devices, investigational medicinal products, sunscreens and cosmetics companies.
She has extensive experience in Qualification and Validation, Quality Systems, Environmental Monitoring Programs, Technology Transfer, Good Warehouse Practice (GWP) projects. With a strong understanding of all phases of pharmaceutical operations – including computerised systems, production, quality control, storage and distribution – she brings the mindset and the expertise to provide in-depth and accurate guidance.
She possesses strong logical and objective thinking, excellent organisational skills and a collaborative mindset. She is flexible, a team player and highly effective in communication and interpersonal skills.
