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.

Farnaz is a senior pharmaceutical professional with over 24 years of experience delivering complex engineering, facility, and validation programs within GMP-regulated environments across pharmaceutical, biotechnology, laboratory, research, and allied life sciences industries. She has extensive expertise in pharmaceutical engineering, GMP operations, and implementing regulatory compliance within production facilities, with a proven track record of leading projects across the full lifecycle, from concept and design through procurement, commissioning, qualification, validation, and operational readiness. Her capabilities include project management and commissioning, qualification, and validation (CQV), as well as pharmaceutical processes and equipment, procurement and tendering, gap analysis and quality risk assessments, and process improvement initiatives, including benchmarking and implementing advanced technologies to enhance manufacturing and packaging operations.

Farnaz holds a Bachelor of Chemical Engineering (Honours), and a PhD in Chemical and Biomolecular Engineering from the University of Sydney, specialising in bioprocess control and optimisation.

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 expertise in GMP-compliant quality systems and operations, specialising in sterile pharmaceuticals. She brings extensive experience in facility qualification, process validation, cold chain management, and product shelf-life studies. Having played key roles in multiple start-up GMP facilities, including the manufacture of sterile injectables and clinical trial materials, Cleo is recognised for her strong critical thinking and ability to design and implement robust, compliant quality systems tailored to business needs.

Cleo also has extensive experience in quality system management in accordance with ISO 13485, as well as in creating and maintaining medical device files, and is a certified ISO 13485 Lead Auditor. She has a proven track record in planning and executing supplier and third-party audits, and in developing and managing risk-based internal audit programs. Cleo effectively supports clients in establishing and maintaining QMS audit schedules, ensuring ongoing compliance and audit readiness.

She has successfully supported numerous clients through TGA audits, contributing to positive regulatory outcomes and strengthening overall quality and compliance frameworks.

Dolores is a highly experienced Operations Specialist with more than 25 years in the pharmaceutical industry, bringing deep expertise across both small‑scale start‑ups and established manufacturing organisations involved in the production and global supply of commercial and clinical trial products.

Her broad technical background includes quality management systems, facility concept design, qualification and validation, facility operations, QMS, risk management, global supply chain management, clinical supply and distribution, and comprehensive end‑to‑end project management.

Dolores has held senior management positions and has played an active role in global regulatory licensing inspections, giving her a practical, solutions‑driven understanding of global GMP requirements. She applies this experience to support clients in achieving strong compliance outcomes and operational excellence.

Her work spans multiple regulated sectors—including pharmaceuticals, biologicals, veterinary products, and complementary medicines—where she is recognised for her collaborative style and her ability to navigate operational challenges with clarity and confidence. Dolores has a Bachelor Degree in Science from NUIG, Ireland.