MaHPharma Pty Ltd
Global Quality Director
An accomplished Quality Professional and Certified Quality Auditor with over 20 years of experience in the pharmaceutical industry.
Experienced in sterile and non-sterile manufacturing, animal healthcare, veterinary products, OTC and Rx medicines, and contract laboratories in areas of QC, QA and packaging. Seasoned in all relevant regulatory guidelines including, but not limited to, PIC/s, TGA, MHRA, CFDA, ICH, ISO, PDA and WHO.
Expertise in aseptic, BFS and H2020 Isolator technology, sterile manufacturing with terminally sterilized products, non-sterile manufacturing with tablets, capsules and suspensions, contamination control, quality management systems, quality risk management, warehousing and distribution, GxP auditing and preparing for regulatory inspections. Well-versed in managing QMS systems including annual product quality review, OOS management, data integrity, CAPA, change control, validation, and quality risk management.