Dr. Rogers has extensive experience in implementing and maintaining ISO Quality Management Systems, International GMP Regulatory Compliance standards, and CE Marking in Pharmaceutical, Medical Device, and Engineering Manufacturing facilities. He has a strong focus on maintaining internal and supplier/vendor qualification programs, computer system validation, meeting production, sales, and profit targets, and optimizing business operations through planning, leadership, and operational activities. He is highly skilled in systems management, quality assurance, and regulatory compliance. His notable achievements include attaining ISO9001 and ISO13485 Certification, CE Mark approval, FDA 510k Approval, Therapeutic Goods Administration (Australia), and Japanese Regulatory Approval.
2023 – Present | Alphaplant Pharmaceutical
2010 – 2023 | Fine Chemicals Corporation (Aspen Group)
2004 – 2010 | Domline (PTY) Ltd.
General Manager | Responsible for all business functions and operational aspects including logistics, procurement, sales & marketing, customer service, HR, and IT. Very much a hands on operation, leading from the front and significantly contributing towards the management of people, product, and equipment whilst achieving the required levels of customer service.
1996 – 2004 | Advanced Medical Technologies (PTY) Ltd.
Quality Assurance & Regulatory Affairs | ManageResponsible for the Quality Assurance and Regulatory Compliance of the manufacture of the Class 1 Sterile safety syringe – SMARTLOCK. Hands on operation implementing the latest chemical and microbiological testing methods for sterile devices before, during, and after manufacture, assembly, packaging, and sterilisation processes. This included the monitoring of a 4000m2 manufacturing plant that was controlled to Class 10 000 (ISO 7) HEPA filtered air.
1995 – 1996 | Genpharm Pharmaceuticals (Alliance Pharmaceuticals)
1992 – 1995 | The Premier Pharmaceutical Company (Adcock Ingram Pharmaceuticals)