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

Director – 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

Learning and Development Director

Maria has over 20 years’ experience in Quality Control, Quality Assurance and Learning & Development management roles in the Pharmaceutical, Medical device and Automotive industries in the Asia Pacific Region. She is a qualified Biological Scientist and educator and routinely trains industry in a wide range of GMP topics including current PIC/S updates, Data Integrity, Quality Risk Management, CAPA, ISO 13485 just to name a few. Maria is passionate about program design and competency assessments that align to business strategy and quality culture.

Maria Mylonas - Training Services Manager

Alison Tennent

Cannabis Compliance Services Director

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

GMP Services Director

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.

Architectural & Engineering Team

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

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

Senior Consultant

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.

Richard Paynter - Lead Process Engineer

Richard Paynter

Lead Process Engineer

Richard has 20 years experience managing capital projects within the secondary pharmaceuticals sector with a bias to front end manufacturing processes for both liquids and solid dose forms.

Key experience & expertise with pharmaceutical quality water systems, product pathway piping systems, mixing vessels, containment isolators, downflow & laminar flow booths and HVAC systems.

Richard has a quality mindset that instils trust and collaborative relationships with QA colleagues and end user stakeholders.

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.

Marina Zmijarevic - Graduate Architect

Marina Zmijarevic

Graduate of Architecture

Marina is a highly motivated professional who thrives on the creative process of architecture and problem-solving. She has logged hundreds of hours, designing and computer modelling, and passionately communicates through drawings to achieve project objectives. Her approach to architecture is grounded by a practical sense of construction, holding a degree in construction management and having experience on building sites. Her attention to detail and importance she places upon collaboration manifests in cohesive and welldocumented drawing sets.  The combination of her education, experience and motivation to excel makes her an asset to the PharmOut team.

Diana Leonardi - Graduate Architect

Diana Leonardi

Graduate of Architecture

Diana is a highly ambitious designer interested in expanding her experience as professional architect, whether it is landscape, exterior or interior architecture. She is confident, hard working and self motivated. Diana is able to work under pressure producing high quality of work on time. She can work efficiently in a team and is eager to build positive relationship with all colleagues and clients.

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.

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.

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.

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.

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

Consultant

James is a consultant who has a broad skill range covering, Validation, Engineering, Training and HR. In his first year at PharmOut, James was 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.

Jeyadev Sreedharan - Senior Consultant

Jeyadev Sreedharan

Senior Consultant

JD has extensive experience in GxP environments as a Computerised Systems Validation expert. He has excellent writing skills and in-depth knowledge of cGMP regulations for both the FDA 21 CFR part 11 and EMA Annex 11 requirements.

He has regularly held responsibility for all GMP computerized systems and data integrity in his job functions and has had oversight on systems that are globally managed, including CAPA systems (Trackwise), SAP and learning solutions.

Robert Kiss - Senior Consultant

Robert Kiss

Senior Consultant

Robert is a Senior Consultant with extensive multi-functional experience across a range of industries utilising QA, IT & commercial skills to successfully deliver optimally validated & implemented systems & services.

With over 15 years’ experience, Robert is considered as one of our experts in Computer System Validation (CSV). He has validated automated manufacturing systems, analytical equipment and IT systems compliant to TGA, GxP, ISO, GAMP5, CFR Part 11, PIC/S Annex 11, CFR 820 and other regulatory requirements.

His expertise also includes project management, business analysis, technical & report writing, IT development, complex trouble shooting, problem resolution, change management, leading multi-disciplinary teams, & training.

John Cannon - Consultant

John Cannon

Consultant

An excellent communicator and results-focused individual, John has several years experience in the areas of sterile manufacturing (both pharmaceutical and medical devices), continuous improvement and equipment and facility qualification.  

John prides himself on his full commitment to every task and he enjoys challenging work environments & problem-solving. He is ambitious and holds himself to very high standards, which is evident through his impressive experience over his years of employment.

Rob Curran - Senior Consultant

Rob Curran

Senior Consultant

Rob is a Senior Consultant, has a PhD in Chemistry and has been working for over 10 years in the pharmaceutical industry in both Europe and Australia. He has experience in laboratory and facility validation for major pharmaceutical companies producing active pharmaceutical ingredients, finished products and sterile blood products, as well as analytical method development to ensure compliance with the TGA, FDA and European regulatory standards.

Astrid Gutierrez - Consultant

Astrid Gutierrez

Consultant

Astrid is a Chemical Engineer with 13 years of experience working in the Quality and Technical areas of various Pharmaceutical Companies. She is a fast learner and good communicator with outstanding interpersonal skills that combined, enable her to communicate at all levels within an organization.

Eleanor Redding - Consultant

Eleanor Redding

Consultant

Eleanor is a Quality Management System professional with over 20 years’ pharmaceutical industry experience, specialising in documentation writing. She has worked in a wide range of pharmaceutical roles with experience in manufacturing, Quality Control and Assurance, research, and lab management, and in a diverse array of fields including human blood and tissue, radiopharmacy, enzyme replacement therapies, vaccines and nutraceuticals. Eleanor uses her broad experience to identify best practices and export them into new environments. The creation of clear, unambiguous and, above all, useful instructive documents is her key driver. 

Connie May MHST - Instructional Designer

Connie May

Instructional Designer | Health Researcher | Medicinal Cannabis

Connie is a health researcher/writer and instructional designer. She has over 20 years’ experience in the medical, healthcare and training sectors. She specialises in instructional course designs including multi-media learning materials, case study research and health industry blog writing. She has worked in a wide range of medical and healthcare fields including pharmaceutical research training, SAE reporting education materials designs, patient-doctor communications, oncology database analysis and coding/reporting, and medicinal cannabis research. 

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.

Silvana has an extensive experience in project management of early phase clinical trials conducted under TGA CTN scheme, clinical trial document development, ethics, and regulatory submissions and Good Clinical Practice (GCP).

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, cleanroom facility start-up, technical writing, quality management systems for sterile pharmaceuticals including vaccines and biologics, and research. Her experience in validation, QC, quality, regulatory and change management, along with her strong investigative skills, make her an asset in the areas of CAPA, OOS, deviations/non-conformances, risk assessment, and gap analysis. She also offers excellent technical capabilities having worked in all areas of laboratory, sterile cleanroom 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.

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.

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.

Meghan Caldwell - Consultant

Meghan Caldwell

Consultant

Meghan is a highly motivated and self driven consultant with over 7 years of international pharmaceutical GMP experience in the areas of Quality and Validation. As part of her MSc in QA and Regulations, Meghan completed a 6 month dissertation project on Mobile Medical Applications and has a keen interest in combining technology with health care.  She has worked on different projects during her career including Data Integrity of GxP systems, the outsourcing of GxP IT operations and various Validation projects. She has experience with Regulatory Inspections, QMS systems and processes and Technical Writing.

Jerome Cheung - Senior Consultant

Jerome Cheung

Senior Consultant

Jerome is a commercially focused, senior management level professional with 15 years’ experience across Pharmaceutical Rx, OTC, Medical Devices (Class I-III), compounded parenteral medicine manufacture, supply chain, regulatory affairs, compliance, quality assurance, validation & verification, engineering and project management for companies operating in ANZ and Asia Pacific.

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.