With more than 30 years of industry expertise gained across Retail, Corporate, Manufacturing and Independent Consulting, Helena van Schalkwyk is a Pharmacist and Pharmaceutical Quality Management Systems specialist, with a solid background in Regulatory Affairs and Pharmaceutical Manufacturing. Multi-skilled with versatile exposure to several specialties within Pharmaceutical Healthcare, Helena retains significant international exposure, with an impressive repertoire of continuous professional development, as well as ongoing collaboration with diverse affiliates, third party contract service providers, colleagues and peers, patients and Healthcare Professionals across the globe. A highly experienced Quality Auditor specialised in Good Manufacturing and Distribution Practices, Helena is up to date with Pharmaceutical Inspection Convention Co-operation Scheme (PIC/S) and World Health Organisation (WHO) GMP requirements, as well as International Council for Harmonisation (ICH) Guidelines, European Union (EU) EudraLex, Volume 4 GMP Guidelines, ISO9001:2015 and ISO13485:2016 Medical Devices Quality Management Systems. Currently, she provides independent Quality Consulting services through her firm, Preminet (Pty) Ltd.