Director / Executive 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 and is recognised as a leading Australian GMP consultant.
Nic van der Nol
Executive Architect and Design Manager. As a building practitioner and a registered Architect, Nic has over 15 years' experience in the detail design, documentation, construction and contract administration of a large range of pharmaceutical, hospital, sterile and non-sterile manufacturing facilities, both locally and internationally.
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).
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).
Jacob has an incredibly diverse experience, whilst initially training as a scientist he has had a proven track record working in highly regulated environments as a chemist, project manager and validation manager. He has led teams in the design, construction and validation of Facilities Equipment and Systems to meet the challenges of a high potency manufacturing environment. He has extensive expertise in process systems and technical transfer projects. Jacob also has excellent technical writing skills, business management and GMP knowledge (FDA, PICs, EMA).
Arguably Australia’s leading expert in validation, Ashley offers over 20 years of practical experience as a qualified Chemical Engineer in GMP-regulated industries (TGA, PIC/S, FDA), including pharmaceuticals, pharmacies, medical devices and blood & tissue organisations.
Ashley has trained regulatory agencies as well as supported start-up companies to find their way through CFR 820, CFR Part 11, PIC/S, ISO 13485 and 14644.
His expertise includes validation, process engineering and GMP compliance, GDP, with specialties in sterile manufacture, HVAC systems and cleanroom design and construction and ATMPs.
Ashley routinely conducts practical gap analysis, performs design reviews and inspections to assist companies develop compliance road maps and support vendor audits.
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.
Bernard is an experienced validation expert having worked for 22 years in the Pharmaceutical Industry with global leaders to regulatory standards (TGA, PIC/S, FDA, ICH, EP/BP/USP). Bernard brings an array of experiences in the areas of production, quality, process automation, process validation, BFS, HVAC, WFI and project management. Bernard’s validation experience includes sterile and non-sterile processes, tablets, powders, equipment, facilities and cleaning.
Senior Engineer, Chemical engineer with over 15 years process engineering experience across pharmaceutical manufacturing, nanoparticles and resource efficiency. He specialises in process design, commissioning, validation, project management and resource efficiency auditing.
Senior Consultant, 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 validation, process engineering and GMP compliance with experience in sterile manufacture, freeze drying, HVAC and cleaning validation.
Underpinning Charles’ technical skills is strong project management, technical writing and training design experience.
Senior Consultant, has over 13 years of experience in biologicals and pharmaceutical GMP regulated environments. Michelle is an experienced engineer in operations, including fermentation, centrifugation, homogenisation, refolding, ultrafiltration and chromatography unit operation. Michelle specialises in project management, process engineering, construction, installation, commissioning and qualification.
Seamus is an engineer with over 10 years of experience consulting to the pharmaceutical and biotechnology industries. His expertise includes regulatory compliance to GMP of international regulatory agencies (TGA, FDA, EU, MHRA, HPRA ISO) and standards (PIC/S, ISO 14644, ISO 9002, IS0 13485). Seamus has extensive experience performing gap assessments, third party and internal QA audits as well as recent practical experience in technical writing, procurement and project management. He routinely works client side to successfully prepare sites for regulatory inspections.
Seamus has experience in CSV design, validation and project management involving process systems, equipment evaluation and qualification and installation and upgrade of pharmaceutical plants.
Alison is a quality systems expert, having delivered many programs over the years to streamline large multinational documentation systems no project is to large or too small. She is a chemical engineer who loves to write, with 18 years of experience in quality-related disciplines within the pharmaceutical, medical device, food services, facilities management and agricultural-chemical industries.
She has successfully implemented effective quality management systems for many clients, both small and large, to meet their business requirements and relevant standards including ISO 9001, ISO 13485, ISO 14001, GLP and GMP.
Alison is able to easily adapt regulations and standards to suit the needs of a client, taking into account the size and business type, and the audience.
Senior Consultant, is an experienced Project Engineer with over 10 years experience in computer system validation (CSV) and protocol development and execution (FAT, SAT, IQ, OQ, PQ). Grant has implemented a variety of IT systems within regulated environments in accordance with industry compliance standards (cGMP, GAMP, 21 CFR part 11).
Alan is a validation professional of over 10 years specialising in Computer Systems Validation. He has extensive experience in GMP, ISO, ISPE GAMP5 and S88 Batch Control standards in the medical device and pharmaceutical industries. He is highly proficient in validating automated manufacturing systems, analytical equipment and IT systems to the FDA 21 CFR Part 11, TGA, PIC/S and EMEA regulatory requirements.
Alan has developed CSV programs including IT quality systems, ERP and mentored companies through implementation. He regularly delivers GAMP5 training. Alan has excellent technical writing, organisation and communication skills.
Consultant, is a Mechanical Engineer offering seven years’ experience working in sterile environments.
Colin has worked in commissioning on capital projects as well as being a validation engineer on the qualification and re qualification of plant equipment. Colin offers technical writing capability having written and executed OQ/PQ protocols and reports for autoclaves, dry heat ovens, cold storage warehouse, freezers, as well as writing and performing characterisation studies for changes to equipment such as vent filter and vial labels.
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
Kent Schoerie is an Industrial Designer working in the life sciences space, he specialises in transforming abstract concepts and ideas in to real models using Building information modelling(BIM) software. His ability to communicate and understand complex briefs are complimented by the way he approaches problems in novel ways that deliver results in time sensitive scenarios.
Working in the pharmaceutical engineering space has exposed Kent to new design principles and ideas, as he continues to be a keen learner applying new ideas and techniques to his work in technical drawing and drafting, whilst adhering to the document/drawing management and control quality guidelines.
Consultant, is a well organised QA and validation professional with a solid background in technical writing, with emphasis on laboratory, manufacturing and and regulatory documentation.
Leah is a strong team-player, capable of leading and managing projects through to completion. She has over 15 years of pharmaceutical industry experience in the areas of GMP, GLP, technical writing and quality management systems.
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.
Consultant, accomplished pharmaceutical professional with international and domestic experience in a number of validation and engineering roles; incorporating her technical knowledge and due diligence, while meeting compliance to all aspects of GMP.
Megan has excellent organisational, communication, and problem solving skills, and is a motivated team player.
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.
Brooke is PharmOut's Financial Manager, with an outgoing friendly, and can do manner she manages to pay everyone on time and juggle the financial responsibilities.
Colin is a GMP professional offering over 9 years’ experience working within pharmaceutical manufacturing, validation and quality environments to TGA, PIC/S and FDA compliance. Colin has worked with both sterile and non-sterile product ranges including biological aseptic manufacture, cellular therapy through to sunscreen and manufacture/packaging pharmaceutical grade (BP) chemicals.
Matt holds an Applied Science degree and over 12 years practical experience working in pharmaceutical and FMGC industries. His roles in life science industries range across validation – equipment and product, QbD product development, coordinating GMP agreement reviews, performing internal audits, supporting regulatory submission CTD preparations, raising and responding to change controls, deviations and QA investigations, supporting TGA and client audit responses, performing vendor assurance, conducting risk assessments, and developing stability protocols and reports.
He has worked on test method development for proteins, emulsions, gels, insoluble powders and novel formulations.
A seasoned pharmaceutical professional with significant validation and management experience. Darren has gained extensive sterile, vaccine and blood fractionation experience in his 30 years. Darren has worked on several major projects including managing a team that validated and optimised the facility and process for manufacture of H1N1 Influenza vaccine associated with a WHO declared global pandemic. And more recently on a variety of blood fractionation products.
He is a proactive, responsible and results focused management professional with extensive experience in the pharmaceutical industry – validation, manufacturing, quality control, R&D and project management roles. Demonstrated ability to manage change and implement system and process improvements.
Able to work effectively at all levels within demanding and challenging environments.
Duncan is an industry veteran with a career spanning more than four decades. He has extensive leadership and project management experience across a multitude of disciplines including Quality Assurance, aseptic processing, validation and microbiology.
Duncan’s pragmatic, and dedicated approach has been the driving force behind the successful completion of projects under his guidance.
Sezgi is a pharmaceutical architect with over 10 years experience in the design, documentation and contract administration of projects. She has also worked on a number of international life science projects.
Sezgi has great organisational and communication skills.
John is a chartered chemical engineer with 19 years of work experience gained in a variety of industrial sectors including research and development, pharmaceuticals, water infrastructure and oil & gas. His key expertise is in facility design, engineering management, commissioning and validation of facilities for the production/handling of chemicals.
He has worked in a variety of job roles including Project Manager/Co-ordinator, Lead Process Designer and Commissioning/Validation Manager. John is familiar with supporting projects at a variety of stages including technology selection, concept development, design, construction, commissioning and validation.
John has worked the last 9 years in Australia.
Justin has over 20 years of experience in FDA, TGA, APVMA and EMEA GMP regulated environments principally in the manufacture of biologicals, ATMPs and pharmaceuticals, including vaccines, CAR T cellular therapies, recombinant proteins, and plasma fractionation, as well as aseptic fill/finish of SMEs. He has over 10 years’ experience in supervisory and management roles in GMP regulated manufacturing environments.
His biotechnology experience spans upstream and downstream operations from 50L to 20kL reactor scale including cell banking, fermentation, centrifugation, homogenisation, refolding, diafiltration, chromatography, filling, and lyophilisation unit operations. His experience encompasses both stainless steel plant and single use systems at large scale.
With the recent changes to the Narcotic Drugs Act 1967 and Narcotic Drugs Regulation 2016, Justin has assisted several clients with applications for medicinal cannabis cultivation, production and manufacturing licences through the Federal Government Office of Drug, with a number now licenced suppliers.
Robert is a university qualified Mechanical Engineering Professional with 10 years project management experience and basic and detail design expertise in HVAC, pipeline and plant construction in Europe and Asia. He has extensive experience working within both the Pharmaceutical and Food Industries, including significant exposure to clean room areas, GMP and aseptic production methods. He has sound experience with ISO 14644, HVAC WHO Guides (solid dosage production) and knowledge of FMEA (failure modes and effects analysis.) He is a motivated leader with proven people management capabilities having successfully lead transactional departments and project teams. He has the ability to communicate effectively and build positive relationships with people at all organisational levels or from different cultural and social backgrounds.
Eriny has many years of experience in the Regulatory and Quality Assurance field. She has strong planning and organisational skills, works well within a team environment and takes pride in the quality of her work.
Her key skills include: conducting internal audits against approved written procedures, conducting external audits of suppliers and contract manufacturers’ facilities that followed TGA, ISO, HACCP or SQF standards and liaised with them to ensure compliance, preparing claims and indications in preparation for listing/registering products and maintaining current product registrations and to ensure continuing compliance with post market regulatory requirements.
Hayley is a scientist with 12 years of work experience. She has worked in various quality-related roles including: Quality Assurance and Compliance Associate, Quality Improvement Officer, Audit Coordinator (for both HACCP and GMP facilities). Hayley also has considerable OHS and quality management systems experience. Hayley has worked at various pharmaceutical and food companies including: Intervet Schering-Plough, Murray Goulbourn and Farm Pride Foods Pty Ltd.
Craig has 15 years of working in highly regulated pharmaceutical and cell therapy facilities for Pfizer, Genzyme, Hospira and Cell Therapies. Craig has extensive experience in quality and validation areas and the capacity to interpret and apply these principles in a number of tasks. He has demonstrated success in facilities using aseptic filling and processing technology, sterile testing, equipment qualification, calibration and validation, quality, and new facility commissioning and start up.
Silvana is an experienced pharmaceutical professional with a strong background in all stages of product development covering GMP, GLP and GCP activities, review and approval of quality SOPs and batch record content.
She is capable of leading and managing projects through to completion. Silvana has over 15 years of pharmaceutical industry experience in the areas of GMP, clean room facility startup, technical writing and quality management systems. Her experience in validation, QC, QA, regulatory and clinical operations and change management, along with her strong investigation skills also make her an asset in the areas of CAPA, OOS and deviations/non-conformances. She also offers excellent technical capabilities having worked in all areas of laboratory, sterile clean room operations and validation over her career.
Sam is a certified Production Engineer with over 8 years of professional Pharmaceutical/Biotech experience in performing and management of: Pharmaceutical and Biomedical Equipment, Process and Facility Projects, Engineering, Preventative Maintenance (PM), Validations (URS, DQ, IQ, OQ, PQ, PV), QMS Documentation (CC, SOP, OI, RA, DR, and CAPA) and Special Development and Scale Up Projects.
Sam has strong problem solving and management skills and a competent versatile background.
Tanja is an ex TGA GMP inspector and a qualified Microbiologist with extensive experience in the pharmaceutical manufacturing of sterile injectable and non-sterile drugs encompassing: quality management, documentation, validation, routine microbiological testing and GLP and GMP compliance.
Her management style is based on strong interpersonal skills, attention to detail, an ability to foster a motivated team environment, excellent communication skills and presentation manner with a strong customer focus.
Dushan is a self-motivated Electrical Engineer with extensive experience working in a wide variety of engineering projects with a diverse range of internal and external stakeholders. His core competencies include: project planning, design documentation and administration.
Darryn Bampton, Executive Consultant, a resourceful Regulatory Affairs and Project management professional with 21 year’s experience in the prescription medicine industry for European, US, Australian and New Zealand markets. Worked with biopharmaceuticals (monoclonal antibodies, oligosaccharides, an autologous T-cell therapy), small molecule new chemical entities, and generics, in numerous therapeutic areas.
A pharmaceutical professional with more than 10 years of industrial experience in both development and regulatory affairs capacity with multinational companies. Qinghong has a wealth of working experience in both drug development and regulatory submissions with various health authorities. He is able to combine the scientific knowledge and legal training to provide strategic advice and practical solutions to an array of technical and compliance challenges in this highly regulated industry.
Maria has over 20 years’ experience in Learning & Development, Quality Assurance and Quality Control roles. She is passionate about embedding strategy and design principles that enable best practice fit-for business operations, delivering holistic solutions and interventions that target key learning outcomes and create a robust learning culture. She has a proven record and expertise in developing and delivering organisational learning strategy and operations to support a wide range of skills set requirements in automotive retail, pharmaceutical and medical device manufacturing industries across the Asia Pacific region.
Jieli is an experienced quality and compliance professional with 10 years of experience in Pharmaceutical and Healthcare industry. She has an in-depth knowledge in GMP, GSP/GDP, ISO 9001 and Compliance Code.
Her key skills include: rich experience in Quality and Compliance Management, including Quality System Document Development, Training Organisation, Audit/Inspection Preparation and CAPA management, experienced in deviation investigation, root cause analysis, action plan development and follow-up, and strong interpersonal, communication and collaborative skills.
Excellent in spoken and written English and Chinese (including Mandarin and Cantonese)
Tony has 24 years of experience working in Mechanical Building Services Consulting. As a mechanical designer he has experience in the detail design, documentation, construction and contract administration of a large range of pharmaceutical, hospital, commercial and institutional projects.