Michael’s experience spans 40 years across a variety of pharmaceutical, medical device, cosmetics, food and FMCG industries. Michael has successfully undertaken numerous projects with a particular focus on project management, site master planning, design co-ordination, GMP and clean room design and facility qualification.
Michael’s qualifications include a civil engineering degree (Hons 1) and a bachelor of science degree.

Stephen’s experience spans 35 years across the pharmaceutical, medical device and veterinary products industries. Stephen’s specialities include facility design, quality systems, GMP, auditing facilities and quality systems, ISO 13485, logistics and information systems. Stephens roles have included extensive experience in Asia and for 2 years in China managed a start-up pharmaceutical facility for a global multinational. Stephen also has been a lead auditor with the TGA. Stephen’s qualifications include a PhD from Sydney University and Bachelor of Pharmacy.

Lesley’s experience spans 35 years across pharmaceutical, medical devices and laboratory facilities, blood and tissue and radiopharmaceuticals.

Lesley’s background in mechanical engineering provides her with a wealth of experience in pharmaceutical facility engineering and design, GMP, GEP and compliance requirements for regulatory bodies including the FDA and TGA. Lesley’s fields of competency include HVAC services design and installation, project management, validation of facilities including HVAC systems, services and process equipment.

Farnaz has an extensive working knowledge of engineering and operations in the pharmaceutical, laboratory, research and allied industries spanning over 22 years in these fields. She has an in-depth understanding of many types of pharmaceutical process and equipment and has excelled in her roles held in the Pharmaceutical Industry by combining her strong academic background with practical engineering and manufacturing skills. Farnaz’s specialties include management and implantation of projects from their inception to completion, contract/tendering management process, facility design, cGMP quality systems, system qualification and validation, quality & safety risk analysis, GEP, GDP, and trouble shooting and problem-solving skills. Farnaz’s qualifications include a PhD in Chemical Engineering from Sydney University and Bachelor (Honours Class) of Chemical Engineering from Sydney University.

Lynne’s experience spans 30 years in the pharmaceutical industry.
Lynne’s specialities include quality systems implementation, quality and safety risk analysis, qualification and validation.
Lynne’s roles have included Research and Development Chemist, Production Manager and Quality Systems Compliance Manager.
Lynne’s qualifications include a PhD in Organic Chemistry, a Masters Degree entitled ‘Free Radical Trapping Methods including 19F NMR to assess Free Radical Activity In Vivo” and Bachelor (Honours) Degree in Chemistry from Liverpool University, UK.
Lynne is also is a Chartered Chemist.

Cleo has in-depth knowledge in GMP compliant quality systems and operations, specialising in sterile pharmaceuticals. Cleo has extensive experience in facility qualification, process validation, cold chain and product shelf-life studies. She has played key roles in multiple start-up GMP facilities, including manufacturing sterile injectables and clinical trial materials, which has equipped her with critical thinking skills and the ability to implement an effective quality system to achieve a high level of regulatory compliance. Cleo has working experience in medical device validation and quality system management (ISO 13485); she has supported many clients in succeeding TGA audits.