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 scientist he has had a proven track record working in a 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).
Lead GMP and Validation Consultant, is a chemical engineer with 20 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.
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.
Bernie is an experienced validation expert having worked for more than 20 years in the Pharmaceutical Industry. Bernard brings an array of experiences in the areas of Production, Quality, Process Automation, Process Validation 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.
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.
Senior Consultant, is chemical engineer with more than 14 years of experience in quality-related disciplines within the pharmaceutical, medical device, food services, facilities management and agricultural-chemical industries.
Alison is a quality management systems specialist and technical writer, and has successfully implemented effective quality management systems for a number of clients, both small and large, to meet their business requirements and the relevant standard.
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).
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.
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.
Colin is a GMP professional offering over nine years’ experience working within pharmaceutical manufacturing, validation and quality environments.
Colin has experience supporting validation and quality operations for aseptic filling, cellular therapy manufacture and non-sterile products, including;
- Qualification of aseptic manufacturing facilities
- Qualification of equipment, including filling, washing, sterilising and temperature controlled equipment and laboratory instrumentation
- Validation of Environmental Monitoring Systems (EMS)
- Design of disinfectant qualification studies
- Electronic Quality Management System (eQMS) setup and administration including Nonconformance investigation and Root Cause Analysis
- Execution of Change Controls in a highly regulated environment
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.
Chris has worked within the Building Services industry for over 12 years, with expansive experience in Building Information Modelling (BIM). This includes large scale projects, utilising the latest technology for clash detection, and modelling systems and spaces all the way from Concept Design, through Construction, and into Facilities Management.
Chris’s HVAC design experience stretches from commercial and residential projects, defence, healthcare, cleanrooms, data centres, laboratories, manufacturing and TV/Radio production facilities.
Chris has experience leading drafting/modelling teams on large scale projects.
Talha is an experienced GMP professional working to PIC/S, TGA and FDA regulatory standards with practical experience in business process mapping, technical writing, validation, temperature mapping, equipment qualification and biomedical engineering.
He has recently supported a large ERP implementation and controlled documentation upgrade project where he delivered project milestones requiring cross-functional collaboration with logistics, procurement, engineering, manufacturing, and quality functions.
Talha is skilled in medical device design, quality assurance and lean manufacturing processes and also has polished communication, reporting, presentation, and project management skills.
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.
As a degree qualified Mechanical Engineer, Brendan is a highly-engaging Consultant with at least 6 years of local and international project-based experience. Brendan’s experience includes engineering and design of HVAC systems and equipment from conceptual stage through to detailed design. Brendan also has experience with the production of tender packages, supplier management, documentation review, factory acceptance testing and construction engineering. Brendan has worked across a diverse range of industries including Pharmaceutical, Laboratory, Petrochemical and Building Services.
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 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 has over 8 years experience in supervisory and management roles in GMP regulated manufacturing environments.
Justin is experienced in upstream and downstream operations from 50 L to 20 KL reactor scale 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.
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
- maintaining current product registrations and to ensure continuing compliance with post market regulatory requirements.