PharmOut Team

Meet the PharmOut team

Pick PharmOut for your next project, that includes Architects, Engineers, Validation or GMP compliance experts from our team.

Management Team

PharmOut has an experienced management team with a proven track record of delivering complex GMP, Validation and Engineering projects on a fixed price or a fee for service basis .

Trevor Schoerie - GMP Consultant

Trevor Schoerie

Managing Director – Executive Consultant

Trevor has over 30 years of practical, hands-on international industry experience ranging across facility design, construction, validation, production and logistics. He has successfully supported many companies achieve US FDA, MHRA or TGA GMP certification, assisted international regulators to achieve successful PIC/S membership and is passionate about seeking innovative ideas to add value.

Trevor has a thorough knowledge and understanding of the whole product lifecycle, being involved in many design and scale up projects whilst in industry and later as a CEO of a Life Science Engineering company before he founded PharmOut in 2006.

Trevor routinely works with and trains both industry and regulators in a wide range of GMP topics including Data Integrity, CSV, FDA CFR 820, ISO13485 and Annex 11.

As founder of PharmOut Trevor is customer focused and driven to ensure PharmOut is up-to-date with international compliance trends and providing our clients receive practical and current support.

Nic Van Der Nol - Pharmaceutical Architect

Nic Van Der Nol

Architectural & Design Manager – Executive Consultant

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.

Maria Mylonas - Training Services Manager

Maria Mylonas

Training Services Manager – Lead Consultant

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.

Maria Mylonas - Training Services Manager

Alison Tennent

Compliance Services Manager – Lead Consultant

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.

Ashley Isbel - Validation Services Manager

Ashley Isbel

Validation Services Manager – Lead Consultant

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.

Seamus Orr - Regional Manager

Seamus Orr

East Coast Manager – Lead Consultant

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.

Architectural & Engineering Team

PharmOut has an experienced team of engineers and architects with a proven track record.

Michelle Edmonds - Senior Engineer

Michelle Edmonds

Senior Process Engineer

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 and containment in high potent APIs. Michelle specialises in project management, process engineering, construction, installation, commissioning and qualification.

Robert Danko - Senior Mechanical Engineer

Robert Danko

Senior Mechanical Engineer

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.

Tony Butler - Senior Mechanical Designer

Tony Butler

Senior Mechanical Designer

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.

Ramin Tavahen - Project Planner

Ramin Tavahen

Project Planner

Ramin is a highly motivated, tertiary-qualified Chemical Engineer and MBA holder with more than 10 years’ experience as a Project Manager. His abilities are collectively unique in the diversity of his skillset, widely distributed across various industries – he has extensive experience operating within pharmaceutical, oil and gas and building and construction industries, with specialist skills in the GMP compliance of pharmaceutical facilities. He has successfully worked on projects with budgets in excess of $150 million USD, sequentially delivering successful project outcomes, both locally and globally.

Sezgi Balin - Architect

Sezgi Balin

Architect

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.

Kent Schoerie - Industrial Designer

Kent Schoerie

Industrial Designer

Kent, working in the life sciences space, specialises in transforming abstract concepts and ideas in to real models. 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, and he continues to be a keen learner applying new ideas and techniques to his work in technical drawing and drafting.

Compliance, Validation & Regulatory Team

PharmOut has an experienced team of consultants specialising in Validation, Compliance and Regulatory affairs with proven track records.

Darryn Brampton - Executive Regulatory Consultant

Darryn Brampton

Executive Regulatory Consultant

Darryn is 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.

Qinghong Lin - Executive Regulatory Consultant

Qinghong Lin

Executive Regulatory Consultant

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.

Tanja Varglien - Lead Consultant

Tanja Varglien

Lead Consultant

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.

John Young - Senior Engineer

John Young

Lead Consultant

John is a chartered chemical engineer with 19 years of work experience. His key expertise is in the process design, commissioning and validation of manufacturing facilities for active pharmaceutical ingredients (APIs) including biopharmaceuticals. He has worked on projects for several pharmaceutical companies including GlaxoSmithKline, Schering Plough, Merck Sharp & Dohme, Pfizer and PPL Therapeutics. John has experience supporting projects at a variety of stages including technology selection, concept development, design, construction, commissioning and validation. John is an experienced risk assessment facilitator.

Bill Smillie - Senior Consultant

Darren Harris

Lead Consultant

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.

Justin Verwoert -Senior Consultant

Justin Verwoert

Lead Consultant

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.

Bill Smillie - Senior Consultant

Bill Smillie

Senior Consultant

Bill is a professional engineer with over 20 years considerable domestic and international pharmaceutical experience in a number of CSV, engineering and quality compliance roles to regulatory standards (TGA, PIC/S). He has been involved as the validation lead in enterprise-wide projects and also as part of multi-disciplinary teams involved with ERP/MRP, BMS, QA and HVAC systems.

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.

Charles Bisignano - Senior Engineer

Charles Bisignano

Senior Consultant

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.

Megan Rutherford - Consultant

Megan Rutherford

Senior Consultant

Megan is an accomplished pharmaceutical professional with almost 10 years international and domestic experience working to TGA, PIC/S, FDA and Health Canada regulatory standards. She has worked 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.

Alan Loughlin - Senior Consultant

Alan Loughlin

Senior Consultant

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.

Criag Flynn - Consultant

Craig Flynn

Consultant

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.

Hayley Taylor - Consultant

Hayley Taylor

Consultant

Hayley is a scientist with 12 years of work experience in various quality-related roles for both HACCP and GMP accredited facilities. Hayley also has considerable OHS and quality management systems experience.
Hayley has worked at various pharmaceutical, botanical API manufacturing and fast moving consumer goods companies including: Intervet Schering-Plough (now MSD Animal Health), Botanical Resources Australia and Murray Goulburn.

Yaara Dromi - Compliance Consultant

Yaara Dromi

Consultant

Yaara has over 11 years’ experience in quality assurance roles, including managerial positions in both global and local pharmaceuticals and blood and tissue organisations. She has excellent knowledge of current GMP, GLP and GCP regulations and wide experience in quality systems, and specializes CAPA and non-conformance investigations.

Yaara provided QA services to support commercial manufacturing, R&D and Clinical studies Supplies for both pharmaceuticals and medical devices.

Colin Byrne - GMP Consultant

Colin Byrne

Consultant

Colin is a Mechanical Engineer offering 10 years’ experience working in sterile environments compliant to TGA, PIC/S, FDA, HPRA and EU regulatory standards.

He 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.

His roles have required him to work across many departments including, validation, quality, quality assurance, quality control, packaging, logistic and the clinical manufacturing facility as well as being involved in FDA, TGA and EU audit response teams.

Colin Webster - Consultant

Colin Webster

Consultant

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.

Jack O'Callaghan - Consultant

Jack O’Callaghan

Consultant

Jack is a highly motivated, fast learning and practical engineer with over seven years of industry experience, predominantly with a leading medical device manufacturer. He has a broad range of competencies across all phases of product development and testing.

Alanna Lean - Consultant

Alanna Lean

Consultant

Alanna is a consultant with international industry experience in Pharmaceuticals and Biologics. With a background in intense production and quality environments, she is highly adaptive, skilled in technical writing and communication and is good at translating regulatory requirements into practical solutions. She also has interests in compliance, streamlining processes and continuous improvement.

James Dickson - Consultant

James Dickson

Technical Assistant

James is a Technical Assistant who has a broad skill range covering, Validation, Engineering, Training and HR. In his first year at PharmOut, James has been heavily involved in all PharmOut’s temperature mapping across, Perth, Melbourne and Sydney. James also assisted engineering in choosing appropriate laboratory equipment for several international companies. James assists the training department with all their training material, including the PowerPoints, Gap analysis excel sheets, Assessments etc.

Eliza Rad - Senior Consultant

Eliza Rad

Senior Consultant

Eliza has over 10 years’ experience in various quality assurance roles in GMP certified pharmaceutical, medical device and investigational medicinal product industries. She has good understanding of production processes and systems in GMP environments, and is passionate about translating regulatory compliance requirements into practical solutions, and continuous improvements.

She is a team player, flexible and with good communication skills.

Varkey Joseph Vettoor - Consultant

Varkey Joseph Vettoor

Consultant

Varkey has been working in GMP environments for around 8 years, and has worked in a variety of technical and quality roles, including validation, compliance, QA and production.

Varkey is self-driven and holds himself to high standards. He understands and has worked with all phases of manufacturing process and his experience is very diverse. It includes data integrity projects, equipment and process validation, statistics, technology transfer, vendor assurance and risk assessment.

NSW Team

Harsha Ramchandani - Senior Consultant

Harsha Ramchandani

Senior Consultant

Harsha is an accomplished engineer with 10 years international and domestic experience in the pharmaceutical and biotech industries to TGA, PIC/S, FDA and ISO standards. She has a sound knowledge of manufacturing, quality systems, GEP, GDP and GMP.

Harsha possesses excellent analytical, organisational and communication skills.

Silvana Sekuloski - Senior Consultant

Silvana Sekuloski

Senior Consultant

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.

Joel Galang - Consultant

Joel Galang

Consultant

Joel is a Chemical Engineer with 16 years of pharmaceutical GMP experience in the areas of quality, computer system validation, manufacturing and distribution.

His practical experience includes:

  • Implementation and validation of laboratory instrument/equipment.
  • Integration and validation of chromatography data system (CDS). Implementation and validation of Laboratory Information Management System (LIMS).
  • SAP Trainer & Power User for Production Process for Process Industries (PPPI), Materials Management (MM), Supply and Distribution (SD), Quality Management (QM) and Warehouse Management (WM) modules.
  • System knowledge: Distributed Control System (DCS) operation, Process Control Systems (with electronic batch documentation), Data Acquisition System (LAN Based Process Automation), Personal Computing/Programming, Web Design and Networking
  • Designing, implementing, training and maintaining quality systems.

 

Joel is a qualified Quality Auditor with experience in petrochemical, pharmaceutical and food (F&B) industry.

Sam Bage - Consultant

Sam Bage

Consultant

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.

Luke Philip - Consultant

Luke Philp

Consultant

Luke is an enthusiastic Validation Engineer with extensive experience in the pharmaceutical industry.

His key competencies include – knowledge of the principles and particulars of validation projects, knowledge of theory and practical use of chemical and biological analysis, data analysis, interpretation and presentation, knowledge of chemical and quality processes. Luke is a team player and has good leadership qualities.

Niamh McAree - Senior Consultant

Niamh McAree

Senior Consultant

Niamh, Senior Consultant, is a quality management systems subject matter expert, vastly knowledgeable in the strategic development, implementation and continuous improvement of existing and new best-practice Quality Management Systems.

Niamh is a results-driven professional with expertise in the implementation of of Quality Systems encompassing the various subsystems of national and international standards; 21 CFR 820,210,211 Regulations / ISO13485 /ISO 9001/cGMP/PIC/s. 

She is a motivated technical writer with experience and fluency in diverse writing styles. Skilled in implementing improvement processes in CAPA, Audit (internal, external, supplier), Complaints, Product Release, Quality System Training, Document Control and Management Review. Niamh is proficient in leaning out processes and test methods for audit risk mitigation.  

As a qualified ISO13485 Internal Auditor, having interfaced and led inspections with global regulatory authority/notified body auditors, Niamh can readily tailor quality systems to meet various regulations and standards, considering the size of the organisation,business needs and the audience. 

Niamh has a strong background in Technical/Design transfer and Contract Manufacturing. She can provide input and review on communications with Regulators for product approval and registration (NADA, ANDA, USP, CBE-30, DMF).

Rashika - Consultant

Rashika

Consultant

Rashika, Consultant, is a quality management systems specialist, highly competent in creating and maintaining technical documentation, and ensuring a state of audit readiness in compliance with regulatory requirements.

Rashika is a results-driven professional with expertise in establishment of QMS processes in compliance with national & international standards and legislation for medical device products ISO13485.

She is a passionate technical writer with experience and fluency in diverse writing styles. Skilled in implementing improvement processes in document control systems, reducing cycle times, improving methodology and process control techniques. Provides active support on use of Insight/BASIS to business stakeholders. 

She is a quality management systems specialist and technical writer, and has successfully implemented effective quality management systems to meet business requirements and relevant standards including ISO 9001, ISO 13485, and GMP. 

As a qualified ISO13485 Internal Auditor, Rashika can easily adapt quality systems to meet various regulations and standards, considering the size and business type, and the audience.

Administration Team

Brooke Harvey - Financial Manager

Brooke Harvey

Financial Manager

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.