Management Team
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
Business 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.
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.
Carl Bufe
Director of Pharmacovigilance
Services
Carl has over 20 years of healthcare experience. He has held various roles in Pharmacovigilance, Regulatory Affairs, Clinical trials, and Quality Management. Apart from his systems, patient, and risk-based approach , he focuses on providing value-adding, cost-efficient and regulatory-sound solutions for his clients.
Carl is a qualified pharmacist and auditor with further qualifications in commerce, risk management and quality system. As a pharmacovigilance professional , he has worked with industry leaders, colleagues, and high-performing staff, various multinational and Australian-specific clients on multiple projects. These projects required him to engage and collaborate with teams in the USA, UK, EU, China, and various ASEAN countries. As regional specific contact person and regulatory intelligence subject matter specialist, he has participated in multiple regulatory inspections (i.e., EMA, TGA and Health Canada).
Carl is passionate about partnering with clients and driving efficiencies.
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.
Natalie Allen
Director Of Regulatory Services
Natalie is a Regulatory, Compliance, Pharmacovigilance, and Medical Professional with over 20 years of experience. She provides expertise and advice in the therapeutic good development, registration and lifecycle management process, providing guidance and implementation of commercial strategies for the successful registration and maintenance of therapeutic goods, including medicines, biological medicines, medical devices, for clientele in Australia, New Zealand, USA, Europe and Japan.
Architectural & Engineering Team
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.
Ramin Tavahen
Lead 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
Warna Foneska
Lead Consultant
Warna is qualified Chemical/Industrial Engineer with 13 years manufacturing and senior management experience in beverage industry and 21 years manufacturing, engineering and operation excellence experience in pharmaceutical industry with extensive knowledge in GMP.
Doug Neumann
Senior Engineer
Doug has over twenty years of experience in project engineering and project management roles in predominately pharmaceutical but also food/dairy industries. His experience has included from small upgrades to complete new facility builds. Inclusive for capex preparation/estimating, scheduling, GMP V model documentation, GMP and OH&S risk assessments, equipment tendering/procurement, FATs, construction, equipment installations, commissioning and GMP qualification.
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.
Reza Bolouri
Architect
Reza is a registered architect and registered commercial builder, having worked broadly in design and construction, including (but not limited to) on-site and off-site project management, occupational health and safety and business development.
Reza is an ISSI fellow (2019) with specific interest in the interaction between builders and architects and has successfully delivered complex pharmaceutical and hospitality projects involving coordination of sub-contractors, contract administration and OHS systems.
A skilled communicator with excellent project management ability and technical construction knowledge. Reza is able to design and review architectural documentation to a high standard, and ensure not only compliance, but identify areas of improvement in constructability and sustainability. This regularly involves work with respect to specialist skills such as specification and safety in design.
Kent Schoerie
Industrial Designer
Kent has a background in Industrial Design and 7 years of experience working in the pharmaceutical design team at PharmOut. Kent specialises in transforming abstract concepts and ideas into real models. His ability to communicate and understand complex briefs is complimented by the way he approaches problems in novel ways that deliver results in time-sensitive scenarios.
With a passion for delivering a user experience that both engages the consumer along the design journey but also provides an end-user result that firmly captures the core design concepts. His ability to use first design principles in addition to producing visual solutions across multiple mediums allows Kent to ensure the user’s requirements are completely captured and visualised.
With a focus on utilizing the latest BIM software and techniques, Kent ensures that the model can be visualised in a single environment allowing for better coordination, advancement of designs, and improved time and cost decision-making.
Compliance, Validation & Regulatory Team
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.
Shane Bourne
Lead Consultant
Shane has over 20 years pharmaceutical experience in both small and large multinational pharma companies (GSK, Pfizer, CSL) covering manufacture of both small molecule and biological products.
He has thorough hands on experience with the manufacture of API’s / Sterile and Non-sterile finished products and intermediates. He also has extensive validation (cleaning, process, and equipment), lifecycle and product/process technical transfer experience both locally and internationally and has managed departments in both manufacturing and validation settings.
Silvana Sekuloski
Lead 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.
Silvana has extensive experience in the development of QMS and other quality documentation required for regulatory approvals and compliance for the manufacture of medicinal cannabis products.
Silvana holds certification for quality auditor (CQA) awarded by the American Society for Quality (ASQ)
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.
Carly Rowlandson
Senior Consultant
For the past 16 years Carly has worked in different roles within the biotechnology, pharmaceutical and supply chain industries including quality, manufacturing and validation. She has worked in environments that are TGA, APVMA, FDA licensed and ISO certified and are therefore familiar with FDA, PIC/S, ISO 9001 and ISO 13485 regulations.
Carly has a Masters in Biotechnology and Business from RMIT University, and a Bachelor of Science (Biological) from Deakin University.
Colin Byrne
Senior 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.
Eleanor Redding
Senior 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.
Eliza Rad
Senior Consultant
Eliza has almost 20 years of experience in diverse GMP compliance roles in various pharmaceutical industry disciplines. Her area of expertise is in the establishment and operation of an effective PQS and Validation program required for regulatory and compliance approval specific to pharmaceutical (including sterile pharmaceuticals), complementary medicines, medical devices, investigational medicinal products, sunscreens and cosmetics companies.
She has substantial experience in PQS, Technology Transfer, Good Warehouse Practice (GWP), Environmental Monitoring Programs and Validation projects.
She has outstanding understanding of all phases of pharmaceutical operations (e.g. production, quality control , storage and distribution), and she has the mindset and skills to offer in depth and accurate expertise.
She has strong logical objective thinking and organisational skills and she is a team player, flexible and has great communication and interpersonal skills.
Meghan Caldwell
Senior 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.
Susan Cheong
Senior Consultant
Susan is a skilled and professional quality and compliance specialist with diverse work experience. She has experience in managing quality assurance systems, leading investigations and audits, and developing effective quality training programs.
Susans key skills are:
- Extensive experience in quality assurance and validation related roles, including experience leading the development and implementation of quality processes, procedures, and systems.
- Demonstrated capacity to oversee manufacturing, with an ability to lead compliance with strict industry and regulatory standards.
- Established problem solving skills with a capacity to troubleshoot production issues in real time.
- Capacity to develop and deliver internal training and professional development programs.
- Strong organisation and time management skills, and experience managing projects and programs.
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.
Tina Christensen-Ram
Senior Consultant
Tina is an experienced quality professional with more than 25 years of experience in the pharmaceutical and medical devices industries. Tina has a broad range of experiences and competencies including the development, implementation and maintenance of quality management systems, management of GMP/GLP compliance and TGA GMP licences across several organisations, management of QC laboratories and environmental monitoring programs.
Throughout her career, Tina has also been responsible for site process and cleaning validation activities and the development and validation of analytical testing methods.
Tina believes in building strong teams, by empowering individuals to be accountable and take full responsibility for their roles. Tina is also a strong advocate for taking cGMP to the next level with continued improvement focus and LEAN manufacturing principles.
Trevor Lavan
Senior Consultant
Trevor is a chemical engineer with extensive experience in pharmaceutical manufacturing processes and facilities, validation and quality systems. He has exemplary written communication skills especially in technical and quality matters.
He has a proven track record of guiding pharmaceutical professionals to complete high-quality work, meeting regulatory and end-user requirements. He is comfortable and experienced in preparing for and participating in regulatory (TGA and FDA) inspections.
Trevor has specialty skills in project management, Oral Solid Dose and other non-sterile processing, and computerised systems.
Carla Medlin
Consultant
Carla has experience in supporting pharmaceutical industries within R&D focused product development, where she has coordinated with multiple international teams. She has supported multiple projects through development and implementation phases of the product lifecycle: including product stability, application testing, product validation, transfers to manufacturing, and product troubleshooting.
Her work has encompassed a wide range of responsibilities including design of experiments in a wet lab environment, finalising D/P FMEAs and risk assessments, writing validation and change control documentation, initiating process improvements, and training manufacturing teams on new processes. She has extensive experience in technical writing, having authored countless SOPs, WIs and other GMP documentation. Carla is adaptable, friendly, and is comfortable working under ISO 9001, ISO 13485, and GMP environments.
Caron Ku
Consultant
Caron is a diligent quality assurance professional with 8 years of microbiology laboratory and more than 2 years of validation experience. She has excellent knowledge in aseptic pharmaceutical facility and equipment and effective communication and interpersonal skills to work with stakeholders from different backgrounds. She enjoys new challenges and problem solving and has demonstrated experience in leadership and team building. Caron places the customer needs first.
Emer Heaney
Consultant
Emer is a highly motivated and driven professional with over 5 years’ experience working as a validation professional in GMP, ISO 9001 and ISO 13485 environments. She has extensive experience and expertise in the fields of computerised systems validation, equipment qualification and working within regulated Quality Management Systems. Emer is equally comfortable working in teams or autonomously. She is a hardworking, detail oriented and technically proficient consultant whose broad experience makes her able to adapt to different project scenarios.
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 Moloney
Consultant
Niamh is an adaptable and quick learner and always strives to apply herself in the best way possible in her role. She has experience in leading teams and has developed great organisation and collaboration skills.
Niamh has experience in the use of prism, global document system firstdocs and gLIMS. She is also adept in technical writing and has authored, drafted, updated and reviewed several CGMP documents and clinical research documents.
Nusrat Hossain
Consultant
Nusrat is a pharmaceutical and biopharmaceutical professional with 6+ years of practical expertise in the development, integration, management, and improvement of quality validation programs for good manufacturing practice (GMP) sites having different multiproducts building blocks including oral solid, liquid, injectables, ointments, ophthalmic, etc.
She has had successive increases in responsibilities and multi-disciplinary duties allowing her to have a broad perspective of validation philosophy, global compliance standards, and how to integrate the two within an efficient and effective Quality System.
Chloe O’Connor
Associate Consultant
Chloe is self driven and a highly motivated consultant with 2 years experience in the pharmaceutical industry. Her experience ranges in areas of Automation, MES, Digital manufacturing and Validation. Previous roles included being part of the Emerging capabilities and supply chain team and Junior CSV Engineer in Janssen Pharmaceuticals company of Johnson & Johnson.
Chloe has worked on various projects during her career involving Self Service Augmented reality, Biometrics for MES, Innovation and representing her team during the manufacturing for the future showcase in depuy sysnthes in 2021.
She has experience with Quality Management Systems and processes, validation and Technical writing.
Peter Nguyen
Associate Consultant
Peter is an adaptable, diligent, and accountable pharmaceutical scientist with a proven ability to provide quality and technical support to production operations and multiple departments.
Peter has experience in QA validation roles, notably in the areas of cleaning validation and processing equipment.
He is an independent decision-maker with the ability to escalate potential issues where appropriate. Peter has excellent project management skills, with demonstrated experience in data collection, review, analysis, and report writing.
Connie May
Instructional Designer | Health Researcher
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.
Amélie Nguyen
Consultant
Amélie is an enthusiastic pharmaceutical bioengineer with a passion for healthcare and people, fueled by 5+ years of experience working with cutting-edge products and equipment in various units of the pharmaceutical industry.
Amélie’s varied work has included R&D, manufacturing operations, capital project management, validation and sales roles. Her blend of technical and scientific knowledge combined with business skills makes her a versatile asset to any team. Amélie possesses exceptional organizational and problem-solving skills and aims to bring positive solutions to any project.
Belinda Lanzon
Lead Consultant
Belinda is an experienced science professional with 20 years pharmaceutical experience in sterile manufacture within quality operations departments, QA /QC. She also has extensive regulatory experience with cGMP, FDA, TGA, EU and works within a highly regulated industry to ensure quality and safety of patients. She is highly experienced in technical knowledge relating to microbiology and regulatory compliance within the pharmaceutical industry.
Administration Team
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.
