PharmOut Team members

Trevor Schoerie

Director / Lead Consultant, is PharmOut's founder and driving force. With Senior, General and Executive Management experience in the pharmaceutical, food and chemical industries in various quality, manufacturing, validation, engineering and consulting roles, Trevor understands the business pressures that can arise from regulatory requirements.

His vision is to provide industry with practical, cost-effective solutions to regulatory challenges.

Email: | View Trevor Schoerie's profile

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: | View Bob Tribe's profile

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: | View Gordon Farquharson's profile

Shelley Tang

Executive Consultant, has worked for the Therapeutic Goods Administration (TGA) across a 20-year timespan, moving from laboratory roles into leading the assessment and regulation of medical devices. Her experience includes the engineering and scientific evaluation of high-risk medical devices, pre-market regulatory assessment of Australian-made devices for International markets, and the implementation of new regulatory frameworks.

Email:

Tony Gould

Tony brings over 20 years' GMP, training and consulting experience to the PharmOut team. His background includes:

• Management within the World Health Organisation (WHO), Geneva
• Chief Auditor with the Therapeutic Goods Association (TGA), Canberra
• University lecturer in Pharmaceutics, Durban.

Tony was awarded an Australia Day medal for work in developing new regulations for medical devices (based on the EU and GHTF models).

Email:

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: | View Andrew Watson's profile

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: | View Ano Xidias's profile

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: | View John Montalto's profile

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: | View Kate Wild's profile

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: | View Ashley Isbel's profile

Bill Smillie

Senior Consultant, is a professional engineer with considerable domestic and international pharmaceutical experience in a number of computer system validation (CSV), engineering and quality compliance roles. He has been involved as the validation lead in enterprise-wide projects and also as part of multi-disciplinary teams.

Bill has a unique ability to rapidly analyse an issue, determine the way forward and take immediate action to progress a solution. This enables him to resolve problems in a minimal time frame for customers.

Email: | View Bill Smillie's profile

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: | View Catherine Chapman-Smith's profile

Charles Bisignano

Charles has over 13 years' experience working in ISO and GMP-regulated environments including pharmaceutical, blood and tissue and water treatment. His key expertise is in the areas of validation (equipment, processes and cleaning), process engineering, GMP compliance, sterile manufacture and maintenance of GMP services and equipment.

Underpinning Charles' technical skills is strong project management, technical writing and training design experience.

Email: | View Charles Bisignano's profile

Craig Bounds

Craig is a senior manager with 16 years' experience in Quality Assurance (QA) and Quality Control (QC) in the Pharmaceutical and Food (Culinary Seed) industries and provides strong knowledge of TGA and FDA regulatory requirements.

He has worked in development, implementation and management of Quality Management Systems including cGMP and ISO9001 and Food Safety Management Systems including HACCP and ISO22000.

Email: | View Craig Bounds's profile

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: | View Debbie Parker's profile

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: | View Eoin Hanley's profile

Ilona Pillai

Senior Consultant, is a scientist with a flair for transforming complex information into structured and succinct quality documents.

Ilona has been writing technical documents on a daily basis for the last 12 years and has worked in a GMP environment (including laboratory, manufacturing, quality and corporate) for the last 7 years. Her strong academic background allows her to engage with technical experts in numerous fields, and convert their knowledge into tangible documents that are suited to the target audience.

Ilona has experience in quality management systems, R&D, Project Management, QA, QC, training and Marketing Research for new product introduction.

Email: | View Ilona Pillai's profile

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: | View James Radnor's profile

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:

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: | View Magan Lai's profile

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: | View Marc Fini's profile

Paul Conway

Senior Consultant, has worked for over 7 years in the pharmaceutical and biotech industries as a validation professional specialising in computer systems validation.

As a project manager he has overseen the implementation of numerous projects of up to $105 million in value.

Paul has excellent technical writing, organisation and communication skills.

Email: | View Paul Conway's profile

Richard Russell

Senior Consultant has over fifteen years Engineering experience offering a strong background in project management, team leadership and as a team member on client sites.

Richard's practical experience includes engineering design & maintenance, validation & commissioning, quality management systems (including development), risk management, change control, training, auditing and health & safety. He has both sterile and non-sterile quality, maintenance and operations experience involving many equipment types, critical utilities and cleanrooms.

He has worked in the UK, Europe and Australia.

Email: | View Richard Russell's profile

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: | View Seamus Orr's profile

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: | View Terry Jeanes's profile

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: | View Alan Loughlin's profile

Anisa Moghaddam

Anisa is a Chemical engineer with five years of experience in GMP regulated industries including API manufacturing and blood fractionation.

She has extensive experience with large capacity based projects in all stages of project delivery, procurement, design, commissioning, qualifications, relocation and providing support during start-up. She has also developed multiple installations, operational qualification protocols, reports, installed equipment systems and performed testing in line with detailed specifications and schedules.

Email: | View Anisa Moghaddam's profile

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: | View Carole Wrench's profile

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: | View Catherine Eleanor Redding's profile

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:

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: | View Heather King's profile

Jay Stacey

Marketing professional, has successfully developed and implemented the marketing strategy for a number of companies. Jay has a wide range of technical skills and is an experienced computer programmer specialising in PHP, JavaScript, CSS and many more.

Email: | View Jay Stacey's profile

Jonathan Nixon

Consultant, is a Chemical Engineer with 9 years experience working in GMP environments. Jonathan has a strong track record in process and cleaning validation as well as equipment qualification.

Jonathan also offers excellent technical writing and proof reading skills and has extensive experience developing protocols, IQ,OQ, PQ documentation, SOPs and has prepared and reviewed product reviews.

Email: |

Jessica Parletta

Jessica is a qualified Pharmaceutical Engineer. Jessica has practical experience in validation and engineering, including BMS/EMS, water systems and biologics manufacturing. Project work includes conducting risk assessments, planning, writing and supervising the execution of process validation protocols and conducting cleaning validation.

She has gained experience working in both chemical and biological manufacturing sites, and is highly proficient at equipment qualifications and GMP compliance.

Email: | View Jessica Parletta's profile

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: | View Justin Verwoert's profile

Kevin Wong

Consultant, has 6 years of experience working as a validation professional specialising in the areas of validation, quality assurance, process engineering and GMP compliance. Extensive experience in the pharmaceutical industries and is highly proficient in validating automated manufacturing systems, clean rooms, and qualification of equipment.

Key expertise is in the areas of validation, process engineering, quality assurance and GMP compliance. Also experienced in ISO9001 Quality Management Systems. Excellent project experience skills, organisational and problem solving skills gained in the pharmaceutical sector.

Email:

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: | View Kylie Prendergast's profile

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: | View Liam Davis's profile

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:

Maria Mylonas

Instructional Designer, has a passion for adult learning and her instructional design methodology includes a highly consultative style to ensure the needs of all stakeholders are analysed and met. She uses current educational theory to create resources that are able to target all types of learners.

Maria has been working within an FDA, TGA, cGMP, ISO 13485 and ISO 9001 environment for the last 14 years. She is experienced in the implementation and maintenance of Quality Management Systems, auditing and process improvement. She has had extensive training experiences in both the Medical Device and Pharmaceutical industries with the delivery of site wide QMS training, staff practical training in quality control testing procedures and the development of training documents and training management systems.

Email: | View Maria Mylona's profile

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: | View Megan Rutherford's profile

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:

Peter Adenuga

Peter Adenuga is a Computer Systems Validation specialist with extensive experience in validation of Pharmaceutical GxP systems. Peter's CSV experience is underpinned by his earlier career as a QA Analyst which enables him to approach business requirement gathering and testing with practical GMP knowledge.

Peter is a security cleared ISEB Certified Senior Test Analyst / Business Analyst specialising in requirements gathering, design and implementation of testing/validation strategies, user acceptance testing (UAT), risk identification and mitigation, change management, business continuity, project management, release management and disaster recovery plans on major projects.,

Peter has led large scale projects, providing coaching, training and mentoring to internal teams of IT / Business professionals and 3rd parties.

Email:

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: | View Rod Garcia's profile

Sam Marchitto

Consultant, has over ten years experience working in GMP environments and technical writing with practical experience in quality processes and systems such as CAPA, Customer Complaints, documentation management and GMP training coordination.

Sam has been involved in Six Sigma, electronic archiving (Documentum) and quality change projects. Sam has excellent technical writing skills and a passion for developing user friendly SOPs and work instructions. His experience includes developing, maintaining and delivering GxP training programs.

Email: | View Sam Marchitto's profile

Sharon Maguire

Instructional Designer, is practiced and experienced in digital resource creation using a range of industry authoring tools, collaborating with SME’s, to develop engaging training and assessment resources. With solid conceptual ability, more than 13 years’ experience facilitating vocational tertiary education in Information Technology and Business, Sharon provides creative LMS e-learning solutions.

An Instructional Designer skilled in Moodle course creation, administration and management, her proficiency extends to working in a LAMP cPanel environment, LMS SCORM integration, and a good working knowledge of HTML.

Email: | View Sharon Maguire's profile

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: