PharmOut Team members
Trevor Schoerie
PharmOut's Managing Director, Trevor Schoerie has 21 years of manufacturing and 8 years of consulting experience in the chemical, pharmaceutical, pesticides & veterinary drugs industries.
Trevor believes strongly in sensible, practical compliance that delivers business results, not just audit success.
His area of expertise is in combining Good Manufacturing Practice (GMP) compliance with continuous improvement methods such as Lean Manufacturing.
Bob Tribe
Bob Tribe is an experienced and approachable industry veteran who has been a key player in the development of the GMP standards and their application within Australia and internationally.
Bob was previously the Chief GMP Auditor for the Therapeutic Goods Administration (TGA), Australia (1980 – 2003) and Chairman of the Pharmaceutical Inspection Cooperation Scheme [PIC/S] (2000 – 2001).
He is a current regulatory advisor to the International Society of Pharmaceutical Engineers (ISPE) and a special advisor to a number of regulatory authorities seeking PIC/S accreditation.
Bob is an Executive Consultant with PharmOut.
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Gordon Farquharson
Gordon Farquharson is widely recognised as a world leader and expert in sterile products manufacture, clean room design and maintenance and utilities for the same.
Gordon is the Chair of British, CEN and ISO committees responsible for development and deployment of the ISO 14644 family of cleanroom standards.
He is also an advisor to the European Medicines Agency (EMA) concerning the revision to Annex 1 of the European Union's GMP in February 2008 and a member of the World Health Organisation (WHO) expert committee (WHO Pharmaceutical Water GMP; Sterile GMP Annex 1).
Gordon is an Executive Consultant with PharmOut.
John Montalto
John Montalto has over 20 years experience in the pharmaceutical and medical device industries.
He is a regular presenter at conferences across the Asia Pacific, and has extensive global experience training companies and regulatory agencies in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Validation and Risk Management.
He is also a Board member of International Society of Pharmaceutical Engineers in Australia and is currently a Consultant with PharmOut.
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Debbie Parker
Debbie Parker has over 25 years experience in the pharmaceutical industry with multinational companies such as GSK and Hospira.
She is an expert in laboratory systems, Good Laboratory Practice (GLP), Computer System Validation (CSV) and Quality Assurance (QA) and is currently a Consultant with PharmOut.
Andrew Watson
Andrew Watson is a chemical engineer with almost 20 years’ experience in construction and engineering. He has significant direct experience in the design and construction of sterile facilities and has an extensive network of suppliers from budget to best-in-class.
Andrew is a Consultant with PharmOut.
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Rod Garcia
Rod Garcia is a computer systems validation professional with over 10 years of international experience in Good Manufacturing Practice (GMP) facilities. Well versed in Good Automated Manufacturing Practice (GAMP5), Rod is currently a Consultant with PharmOut.
Terry Jeanes
Terry Jeanes has been involved in the development of automation and IT software for over 18 years, including 15 years in the pharmaceutical industry.
He has proven experience in preparing comprehensive documentation, including traceability requirements through design and testing, and meeting various IT-related compliance standards (ISO 9001, 21 CFR Part 11, FDA, Good Automated Manufacturing Practice (GAMP5), TGA requirements, etc).
Terry is a Consultant with PharmOut.
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Ashley Isbel
Ashley Isbel is a chemical engineer with over 15 years experience in GMP-regulated industries, including pharmaceuticals, medical devices and blood & tissue organisations. His areas of speciality include aseptic processing, validation, process engineering, production and training.
Ashley is a Consultant with PharmOut.
Dr. Kathy Walsh
Kathy Walsh is a scientist and experienced technical writer with over 10 years experience within the pharmaceutical industry.
She has experience in quality management systems, change management, research & development, Quality Assurance and Quality Control processes, quality documentation and training requirements. Kathy's varied experience both in the pharmaceutical industry and research arena includes managing quality documents, records and staff, interpreting pharmaceutical/environmental data and implementing a variety of quality projects/systems.
Kathy is a Consultant with PharmOut.
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Alison Tennent
Alison Tennent is a chemical engineer with a background in process and equipment validation within the pharmaceutical and medical device industries.
Alison is a competent technical writer and quality systems consultant and has successfully delivered suitable and effective quality management systems to a number of our clients.
Alison also has experience in the principles of Good Laboratory Practice (GLP), routinely working as a quality assurance manager for our clients.
Alison is a Consultant with PharmOut.
Ann (Nai Yee) Choong
Ann (Nai Yee) Choong holds a MSc. in Pharmaceutical Technology from the University of London and spent five years with the Health Sciences Authority in Singapore, both as a regulatory scientist and as a GMP Auditor.
Anne has extensive experience in auditing for GMP compliance within facilities manufacturing active pharmaceutical ingredients, medicinal products and Chinese proprietary medicines. She was also part of the working group responsible for developing the inspection framework for Cell and Tissue therapy facilities.
Anne is a Consultant with PharmOut
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Dr. Feng Ying Zhao
Feng Ying Zhao has experience in Good Manufacturing Practice (GMP) auditing, regulatory affairs and laboratory analysis and validation.
During her career, she has shown an aptitude for working and communicating well with a diverse range of people, making her a valuable team player. Feng Ying is a fluent Mandarin speaker.
Feng Ying is a Consultant with PharmOut.
Steven Luty
Steven Luty is a validation professional specialising in computer systems validation. He has extensive experience in the medical device and pharmaceutical industries and is highly proficient in validating manufacturing computer systems, laboratory analytical equipment and clean room (EMS Systems) environment to international regulatory standards.
Steven is a Consultant with PharmOut.
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