Dr. Gregory Rogers

Head of Compliance & Quality Assurance

Dr. Gregory Rogers

Head of Compliance & Quality Assurance

Biography

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.

Chronology

2023 – Present | Alphaplant Pharmaceutical

Head of Compliance & Quality Assurance

2010 – 2023 | Fine Chemicals Corporation (Aspen Group)

Quality Assurance & Site Compliance Manager | Responsible for all Quality Assurance activities on site. This includes all documentation from Standard Operating Procedures through to Production Documentation. All cGMP and SOP training etc. fall under the QA Department to ensure compliance to the FDA, ICH Q7 and other Regulatory authorities.

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)

Quality Assurance Manager | Responsible for all quality control and quality assurance functions throughout the manufacturing facility. This included ensuring that the Good Manufacturing Practices complied with acceptable standards that enabled Genpharm to manufacture products for companies such as 3M.

1992 – 1995 | The Premier Pharmaceutical Company (Adcock Ingram Pharmaceuticals)

Group Microbiologist | Responsible for all Quality Control and Quality Assurance microbiological aspects of 5 manufacturing facilities including an animal health facility. Involved in and implemented “clean manufacturing practices” in the tablet pressing areas to ensure minimal contamination of product that did not have preservatives incorporated in their formulations. Implemented emergency planning procedures at the various sites and was part of the Midrand Crisis Committee and sat on the Agricultural & Land Use Committee for the Environmentally Safe Management of Dangerous Materials.

Dr. Gregory Rogers

Head of Compliance & Quality Assurance