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Parenteral Drug Association Connecting People, Science and Regulation ®

About the Australia Chapter

Eoin Hanley, President eoin.hanley@cslbehring.com.au
Eoin is currently a Quality Assurance Projects Compliance Manager with CSL Behring. Eoin has worked in the pharmaceutical & biotech industries in Europe, the USA and Australia/Pacific, with some of the largest companies in the world. He has experience in a variety of roles within Quality, Engineering, Qualification/Validation and consulting. Eoin has worked on a range of products from API's to sterile medicinal products, including blockbuster recombinant proteins. Eoins experience comes from a background in Analytical Chemistry and an MSc. in Pharmaceutical Validation. He also has a passion for keeping up to date with current regulatory and industry trends, as well as the application of lean and operational excellence approaches.

Lisa Bennett, President Elect Lisa.Bennett@seqirus.com
Lisa is currently a Senior Associate in Quality Assurance at Seqirus, the newest member of the CSL Group. Lisa has 8 years’ experience in the pharmaceutical industry and in this short time has grown through a number of roles within Quality Control, Stability, Clinical Trials, R&D, Aseptic Fill & Finish and more recently in Quality Assurance. Lisa’s experience comes from a background in forensic & analytical chemistry accompanied by a Masters in Forensic Science.

David Spaulding, Immediate Past President david.spaulding@seerpharma.com.au
David has over 30 years experience in the pharmaceutical and dental industries, in Research and Development, Logistics Management, Training, Manufacturing (including aerosols, sterile and non-sterile dosage forms) and Sales and Marketing. He has also owned and managed small to medium sized pharmaceutical companies, specialising in delivering substantial growth and technical expertise. David is currently a senior consultant with SeerPharma Pty. Ltd.

Paul Kerr, Treasurer paul.kerr@seerpharma.com.au  
Paul is a Partner of SeerPharma and has over 30 years broad pharmaceutical experience across various technological areas (scientific and IT) as a qualified chemist and an IT project manager. Paul is a qualified PDA Software Supplier Auditor and conducts IT gap analysis and compliance audits for companies. Paul is experienced in computer validation and assists companies establish IT compliance and computer validation programs. He has been a member of the PDA for many years and served on the committee since 2004.

Dina El-Emary, Secretary dina.el-emary@cslbehring.com.au
Dina has over 12 years of experience working in the medical devices and pharmaceutical manufacturing industries.  Currently she is the Quality Compliance & Improvements Manager at CSL Behring.  She is a qualified Mechatronics Engineer and has had varied roles in Engineering, Manufacturing and Quality Assurance, bringing in every role improvements in quality, efficiencies and business process effectiveness.  More recently she has been the lead in significant site-wide compliance improvements at CSL Behring.

Mark Dickson, Committee Member mark.dickson@cslbehring.com.au
Mark Dickson is a Director, Quality Assurance Compliance, at CSL Behring Broadmeadows. Mark was previously a Senior Global Quality Manager at Novartis International AG managing significant quality incidents and escalations for Novartis Technical Operations and performing GxP audits on behalf of the Pharma QA Compliance & Auditing Group. He also provides expert GMP advice to Pharma QA, assisted in GMP training, supported global commitments and continuous improvement initiatives. Mark previously worked for the Therapeutic Goods Administration (TGA), Office of Manufacturing Quality (OMQ) for 8 1/2 years. Prior to the TGA, Mark worked for 13 years in both quality and manufacturing roles within the pharmaceutical industry.

Paul Doughty, Committee Member pauledward@bigpond.com 
Graduating in 1982 with a degree in Medicinal and Pharmaceutical Chemistry (J. Hons.) Paul has spent his professional career working in the Pharmaceutical and Biotechnology industries and has wide ranging experience with local and international companies and in various consultancy roles. He has been a PDA member since 2006.

Usha Gulapalli, Committee Member usha.gullapalli@pfizer.com
Usha has more than 25 years of experience in Pharmaceutical Industry and with a proven track record of building and leading teams/organizations that deliver results. Over the course of her career, she has demonstrated flexibility and the ability to quickly learn new skills in successfully switching between R&D, Quality and Operations. Usha believes that everyone in an organization has the ability to “Make a Difference” through a culture of accountability and open communication. She has been successful in driving this type of culture and her group has been recognized as the highest performing team in the organization.

Trevor Schoerie, Committee Member trevor.schoerie@pharmout.net
Trevor, Director and 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.

Maria Mylonas, Committee Member maria.mylonas@pharmout.net
Maria has over 20 years’ experience in Learning & Development, Quality Assurance and Quality Control Management 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 is currently the Training Services Manager at PharmOut.

Justin Verwoert, Committee Member justin.verwoert@spectrumcannabis.com
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 shake flask to 20kL reactor scale. His experience encompasses both stainless steel fixed plant and single use systems at large scale.

Micheal Schafferius, Committee Member micheal.schafferius@Sartorius-Stedim.com
Micheal has worked in the pharmaceutical and biopharmaceutical industries for more than 15 years. His experience includes roles focused on Filtration, Single Use Technologies, Quality Assurance, Validation and Sterile Manufacturing with local and international companies. Currently Micheal is a specialist for filtration and quality at Sartorius Stedim Biotech.