PharmOut Team members

Trevor Schoerie

Director / Lead Consultant, is an experienced, approachable industry veteran with Senior, General and Executive Management experience in the pharmaceutical, food and chemical industries in various quality, manufacturing, validation, engineering and consulting roles.

Email: trevor.schoerie@pharmout.net

Bob Tribe

Executive Consultant, is an experienced, approachable industry veteran, previous senior TGA auditor and key player in the development of the GMP standards (PIC/s, WHO, TGA, ICH) and their application for multiple regulatory authorities (Asia/Asia Pacific, Middle East, Africa, Europe).

Email: bob.tribe@pharmout.net

Gordon Farquharson

Executive Consultant, is a Chartered Engineer with a unique blend of regulatory, technical and operational experience. He has conducted a broad spectrum of international audits, inspections and training assignments, encompassing technical aspects, GMP compliance and operational due diligence.

Gordon is also active in developing standards and guidance within the global pharmaceutical industry (PIC/s, EU, FDA, WHO).

Email: gordon.farquharson@pharmout.net

Andrew Watson

Engineering Director / Lead Engineer, has over 17 years’ experience in the pharmaceutical industry, having worked in both Australia and Ireland. He has designed and built a number of cleanrooms and their associated systems and processes. He brings a wealth of practical, workable and cost-effective design and construction solutions to life science projects.

As a project manager he has overseen the implementation of numerous projects of up to $65 million in value.

Email: andrew.watson@pharmout.net

Ano Xidias

Lead Consultant, has extensive knowledge of sterile manufacturing and quality systems in the global pharmaceutical market and has worked in the industry for over 20 years. His management roles include QA, QC, manufacturing, compliance, sterility assurance, product release and process validation.

Ano is experienced in both developing and auditing quality systems in GMP and GLP regulated environments. He has a strong knowledge of plant compliance, validation and laboratory and manufacturing operations. Ano’s expertise includes establishing systems to improve compliance, efficiency, effectiveness and safety of work processes.

Email: ano.xidias@pharmout.net

John Montalto

Training Manager / Lead Consultant, has more than 15 years’ experience in multinational companies in the pharmaceutical and medical device industries.

He has extensive global experience as a trainer and course facilitator, developing training programs and training companies and regulatory agencies in Good Manufacturing Practice, Validation and Quality Risk Management.

John is also an experienced auditor and expert Quality Risk Management facilitator with thorough Quality Management Systems knowledge and understanding.

Email: john.montalto@pharmout.net

Kate Wild

Lead Consultant, is a seasoned project and change implementation professional offering over fifteen years’ experience which includes leading and supporting FDA and TGA audit response teams in Australia. She also has experience with large scale change programs in the Middle East and Asia.

Kate offers practical guidance in program management with strong expertise in design, implementation of project management functions, QMS management, training design and technical writing.

Email: kate.wild@pharmout.net

Ann (Nai Yee) Choong

Senior Consultant, is a regulatory professional with excellent practical experience in regulatory affairs, QA, GMP and validation, including pre-marketing evaluations and conducting on-site inspections of manufacturers in accordance to the current PIC/S Guide to Good Manufacturing Practice (GMP) for Medicinal Products and the Medicines Act.

Inspections include, active pharmaceutical ingredients, medicinal products and Chinese proprietary medicine facilities. Dosage forms inspected include sterile, solid and liquid preparation.

Email: ann.choong@pharmout.net

Ashley Isbel

Senior Consultant, is a chemical engineer with over 17 years experience in GMP-regulated industries, including pharmaceuticals, pharmacies, medical devices and blood & tissue organisations.

His key expertise is in the areas of validation, process engineering and GMP compliance, with specialties in sterile manufacture, HVAC systems and cleanroom design and construction.

Email: ashley.isbel@pharmout.net

Debbie Parker

Senior Consultant, is a well organised QA and validation professional with a solid background in computer systems and analytical chemistry and excellent writing skills. She holds a BSC in chemistry and a postgraduate diploma in Engineering - Industrial Information Technology.

Debbie is a strong team-player capable of leading and managing projects through to completion. She has over 25 years of pharmaceutical industry experience in the areas of GMP, GLP, quality management systems, auditing, audit remediation, technical writing, computer systems validation, equipment validation and analytical method validation.

Email: debbie.parker@pharmout.net

Eoin Hanley

Senior Consultant, has worked for over 12 years in the pharmaceutical and biotech industries on products including APIs, small molecular products, blockbuster recombinant proteins and IV solutions.

He has experience in the areas of development, quality control, quality assurance, validation, engineering, regulatory affairs and lean manufacturing.

Eoin has strong knowledge of GMP/QMS systems and regulatory compliance in US, EMA and TGA regions.

Email: eoin.hanley@pharmout.net

James Radnor

Senior Consultant, is a chemical engineer specialising in validation, quality systems and project management. He has extensive experience in process development, design and implementation of new GMP facilities and equipment. James has conducted multiple supplier ISO9001 audits and Factory Acceptance Tests and has broad knowledge of European CGMP regulations and developments.

Email: james.radnor@pharmout.net

Kathy Walsh

Senior Consultant, 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, R&D, QA and QC and training.

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.

Email: kathy.walsh@pharmout.net

Magan Lai

Senior Consultant, is a Computer Systems Validation specialist with extensive experience in validating Pharmaceutical GxP systems. He has been in the industry for over 10 years and has been involved in a number of validation projects utilising his excellent leadership, communication and organisational skills.

Email: magan.lai@pharmout.net

Marc Fini

Senior Consultant, has over 15 years of experience in the pharmaceutical industry, principally in the roles of validation and compliance. He has experience in API, solid dose, liquids and blood products facilities and provided validation services to a wide range of companies in Australia and Asia.

Marc has worked in various Project Management roles, HSE roles and in the implementation of ISO 9001 compliant management systems.

Email: marc.fini@pharmout.net

Seamus Orr

Senior Consultant, has over 10 years of experience consulting to the pharmaceutical and biotechnology industries. His expertise includes regulatory compliance, technical writing, procurement and project management.

Seamus is an engineer and is experienced in design, validation and project management involving process systems, equipment evaluation and qualification and installation and upgrade of pharmaceutical plants.

Email: seamus.orr@pharmout.net

Steven Luty

Senior Consultant, is a multi-skilled, articulate, validation professional specialling in computer systems validation with extensive experience in the medical device and pharmaceutical industries.

He is highly proficient in validating manufacturing computer systems, laboratory analytical equipment and clean room (EMS Systems) environment.

Steven’s key skills include technical problem solving, planning and leadership. Highly motivated with excellent communication and interpersonal skills. Proven record demonstrating commitment to quality and attention to detail.

Email: steven.luty@pharmout.net

Terry Jeanes

Senior Consultant, 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, 21CFR part11, FDA, GAMP, TGA, etc).

Terry is an excellent communicator with experience in staff management. He is adaptable to work within a variety of company or team structures.

Email: terry.jeanes@pharmout.net

Alan Loughlin

Consultant, 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 automated manufacturing systems, analytical equipment and IT systems to the FDA 21 CFR Part 11, Good Automated Manufacturing Practice (GAMP5) and other international regulatory requirements.

Alan has excellent technical writing, organisation and communication skills.

Email: alan.loughlin@pharmout.net

Anisa Moghaddam

Consultant, is a chemical engineer who has spent the first part of her career performing validation and engineering operations for a state-of-the-art API facility.

Anisa’s experience includes the validation of a 4000L reactor heat transfer system, management of the purified water system, preventative maintenance and calibration. Her role at PharmOut involves her working in validation and project engineering.

Email: anisa.moghaddam@pharmout.net

Carole Wrench

Quality professional with a strong background in quality systems and validation.

Skilled in manufacturing systems compliance, process and equipment validation in both Sterile and Aseptic processes, with more than 25 years of Manufacturing experience gained across quality assurance and product development departments.

Email: carole.wrench@pharmout.net

Catherine Chapman-Smith

Consultant, is a chemical engineer with experience consulting to the pharmaceutical and biotechnology industries. Her expertise includes regulatory compliance, technical writing, procurement, and project management.

Catherine has experience in aseptic vial fill and finish, pre-filled syringe, lyophilisation and containment technologies.

Email: catherine.chapman-smith@pharmout.net

Eleanor Redding

Consultant, is an experienced pharmaceutical professional having worked in several areas of the industry from quality control management to medical communication.

Eleanor uses her background of science and language to produce clear and robust documentation for pharmaceutical and medical device companies.

Email: eleanor.redding@pharmout.net

Harsha Ramchandani

Consultant, is an accomplished engineer with international and domestic experience in the pharmaceutical and biotech industries. She has a sound knowledge of manufacturing, quality systems, GEP, GDP and GMP.

Harsha possesses excellent analytical, organisational and communication skills.

Email: harsha.ramchandani@pharmout.net

Heather King

Consultant, offers over eight years’ experience as a Technical Writer and Trainer within regulated environments. With an education in life sciences and extensive international experience, her analytical research, presentation and communication skills are excellent.

Heather’s varied experience includes technical writing, proof reading and corporate writing, as well as developing e-learning content.

Email: heather.king@pharmout.net

John Dimitriadis

Consultant, is a customer focused IT Specialist with a science background and extensive experience in the healthcare industry.

He is a skilled trouble-shooter with an analytical mindset and ability to see problems to resolution. John is a self-starter with enthusiasm to learn and interact with new systems with minimal training.

Email: john.dimitriadis@pharmout.net

Justin Verwoert

Consultant, has over 12 years of experience in FDA, TGA, APVMA and EMEA GMP regulated environments, principally in the manufacture of biologicals and pharmaceuticals, including vaccines, recombinant proteins and plasma fractionation as well as aseptic fill/finish of small molecular entities.

He is experienced in upstream and downstream operations, including cell banking, fermentation, centrifugation, homogenisation, refolding, diafiltration, chromatography, filling and lyophilisation unit operation.

Justin also has exposure to validation of new and existing equipment, remedial validation programs, cGMPs for APIs and finished goods, design and renovation of clean room facilities, water systems, OGTR requirements, six sigma, problem solving and decision making methodologies.

Email: justin.verwoert@pharmout.net

Kylie Prendergast

Consultant, is an experienced validation consultant able to validate large-scale production processes in complex computer controlled / automated biotechnological environments.

Kylie has experience with process steps such as CIP, SIP, viral inactivation and purification and has successfully coordinated and conducted commissioning and validation activities within tight project timelines.

Email: kylie.prendergast@pharmout.net

Liam Davis

Consultant, has over 10 years’ experience in the pharmaceutical industry with a leading global company. Recently Liam worked in Regulatory Affairs but earlier roles included working in manufacturing (solid dose) and raw materials QA / QC with increasing responsibility and focus on GMP compliance.

Liam is experienced in driving change, working with multi-disciplinary teams and has regularly delivered GMP and Induction training throughout his career.

Email: liam.davis@pharmout.net

Liz Cotter

Consultant, is an experienced pharmaceutical professional with operational, GMP, validation and project management experience. She has excellent co-ordination, communication, leadership and problem solving skills with experience in the pharmaceutical and medical device sectors both in Europe and Asia-Pacific regions.

Liz is a competent, motivated team player who has worked within GMP, ISO and GAMP5 frameworks for facilities required to meet TGA, FDA and PIC/S guidelines.

Email: liz.cotter@pharmout.net

Megan Rutherford

Consultant, is an accomplished pharmaceutical professional with experience in manufacturing and packaging and cleaning and equipment validation. She has a sound knowledge of GMP and has worked in international facilities, providing technical advice and writing documents to meet FDA, TGA, HPFBI and PIC/S standards.

She has excellent project management, organisational and problem solving skills gained in the pharmaceutical sector. Megan is a motivated team player with excellent communication skills.

Email: megan.rutherford@pharmout.net

Mylinh Ly

Consultant, has almost 10 years experience in the pharmaceutical industry, with practical knowledge in R&D, Quality Control, Quality Assurance and Validation.

My Linh has a strong focus on quality and technical writing, project coordination and excels in troubleshooting.

Email: mylinh.ly@pharmout.net

Rod Garcia

Consultant, has a broad background in IT and Computer System Validation. He has over 9 years experience in the pharmaceutical and medical device industries gained through a number of roles, both within Australia and overseas.

Email: rod.garcia@pharmout.net

Sha Xu

Consultant, is a recent Mechanical Engineering graduate who is fluent in English, Cantonese and Mandarin. Sha has worked in Australia and China, translating and writing technical and validation documents for a major pharmaceutical company. He has also assisted in the design of a major hospital pharmacy, the refurbishment of an existing pharmaceutical facility and the fitout of a microelectronic research facility.

Email: sha.xu@pharmout.net

Shiau Houng Tan

Consultant, has a wide range of experience in generating and revising documentation for quality management systems and regulatory submissions. She has established risk management systems, implemented lean manufacturing and conducted regulatory audits in the medical device and other industries.

Email: shiau.tan@pharmout.net

Tracy Lay

Consultant, IT Quality professional with a strong background in computer systems. Tracy is skilled in computer systems validation and GMP, with a number of years of pharmaceutical industry experience. Offering 26 years experience in IT gained across validation, software analysis and development, documentation, training and support.

Tracy’s background includes large scale projects in pharmaceutical, manufacturing, sales and distribution industries.

Email: tracy.lay@pharmout.net