Wayne Muller Email & Phone Number

An accolade for me was joining the Public Sector enabling me to be part of a Regulatory team, not only representing the Regulatory Authority as the Chief Auditor but also the many patients who rely on the safety, quality and efficacy of the manufactured medicines. My auditing profile extends from Applicants, Warehouses, Medical Depots, OSD, LCO, General Sterile, Beta lactams, Cytotoxic and Biopharmaceuticals including vaccines. Quality standards are what my previous roles demanded of me to comply with. I have operated within the fields of Manufacturing, Quality and Compliance and Project Management. I have sound knowledge and am well versed on the various policies and legislation including the National Drug Policy, Pharmacy Act, Medicines and Related Substances Control Act, Occupational Safety Acts, SA GMP Guide, PIC/S guide, WHO guide, Eudralex, TGA, FDA, MHRA.

• Chief Auditor

  Sahpra

  Sep 2012 - Present - South Africa

  I conduct cGMP at various local and international pharmaceutical and chemical facilities. These include Complementary and Alternative Medicines manufactures. I am responsible to compile and issue audit reports to the various companies, involved with the approval and rejection decisions in terms of GMP Compliance. on licensing and pharmacovigilance inspections and reviews. The activities follow the PIC’s, WHO, ICH, MHRA, FDA, European guidelines. The primary guideline followed is the South… Show more I conduct cGMP at various local and international pharmaceutical and chemical facilities. These include Complementary and Alternative Medicines manufactures. I am responsible to compile and issue audit reports to the various companies, involved with the approval and rejection decisions in terms of GMP Compliance. on licensing and pharmacovigilance inspections and reviews. The activities follow the PIC’s, WHO, ICH, MHRA, FDA, European guidelines. The primary guideline followed is the South African, GMP guide. Key Performance Measures are: Plan adherence to Audit Schedule, On time inspection report percentage and Time lag for issuing of the report presenting the response to the various regulatory committees. International Sites that I have audited include India (Goa, Ahmedabad, Pondicherry, Pantnagar, Mumbai, Navi Mumbai, Dehradun, Roorkee, Hyderabad) Paraguay, Brazil, Mexico, China, Jordan, Oman, Saudi Arabia, Vietnam, Indonesia, Greece, Ireland Show less

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  University Of Cape Town

  Pharmacy