Partner & Software Products and Services Manager
Rohan joined SeerPharma in 2012 and now leads the Software Products and Services team. He has gained extensive experience designing, developing and implementing quality management software solutions across multiple industries. Rohan has a strong track record in Project Management, Business Systems Analysis, Computer System Validation and most importantly in delivering projects that meet and exceed customer expectations. Rohan became a SeerPharma Partner in 2019.
Partner & Senior Consultant
Paul has over 35 years broad pharmaceutical experience across various technological areas (Laboratory, Manufacturing and IT) as a chemist and an IT project manager. As a qualified Software Supplier Auditor (PDA TR 32) Paul conducts IT gap analysis and compliance audits for companies (ISO/IEC 9000-3, ISO/IEC 62304, ISO/IEC 12207). He trains in computer validation (US FDA 21 CFR Part 11 and GAMP) and assists companies establish IT compliance and computer validation programs. Paul also conducts simulated FDA and TGA compliance audits and gap analysis for several international medical device and pharmaceutical companies (US FDA 21 CFR Part 820 and Part 11, PIC/S Annex 11, ISO 13485, ISO 14971). He regularly gets involved with specific validation projects using automated systems in clinical, manufacturing and laboratory environments.
Partner & Customer Solutions Business Manager
Ian has over 30 years experience with software development and implementing computerised systems. He has successfully designed and implemented many quality management and manufacturing solutions for the pharmaceutical industry and other regulated industries. Ian manages the Customer Solutions Business that works closely with customers to deliver validated customer-focused IT solutions with virtually any software platform. Ian regularly presents training courses and seminars on practical approaches to computer validation.
Partner & Training Manager
David has over 30 years’ experience working for companies such as GSK, DBL (now Pfizer), Hydration Pharmaceuticals and now SeerPharma. He has been appointed in various roles such as R&D chemist, Production Manager, Logistics Manager, Sales and Marketing Manager and CEO. In his current role, David oversees SeerPharma’s Training Division, including our collaboration with the University of Technology Sydney, to offer Asia-Pacific’s sole Postgraduate course on Good Manufacturing Practice (GMP). He is a past President and current Committee Member of the PDA (Australia Chapter). David holds a Honours Degree in Chemistry from Monash University and a Graduate Diploma in Business Administration from Swinburne University of Technology.
Partner & Senior Consultant
Louise has over 35 years experience in the pharmaceutical industry. This includes 13 years experience in a sterile vaccine manufacturing company, CSL and over 22 years within SeerPharma. While in the industry, Louise held roles in Virology R & D, Bacterial Vaccines Production, Quality Control and Production Planning. One of her key roles in SeerPharma is to design, develop and deliver training and education programs relating to GxP compliance and product quality improvement programs.
As a senior GMP consultant Louise has worked with many biopharmaceutical organisations to design and implement Quality Management Systems to a variety of standards including: TGA, ISO, FDA and European cGMP standards. She has also worked on many major validation projects for both sterile and non-sterile multinational companies.
Louise is a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA) and in this role, conducts GMP licencing audits on behalf of the Australian Government.
Tony has over 45 years experience in the pharmaceutical industry, specialising in compliance to FDA and PIC/S GMPs and sterile product manufacturing. Tony successfully directed a start-up GMP consultancy to be the largest and most successful GMP consulting firm in Australia. He has project managed validation and licencing (FDA and TGA) of GMP facilities. Tony assisted in the design and implementation of national public GMP training programs, including University programs for supervisors and managers in Australia and Malaysia.
Principle areas of expertise include Human Bacterial Vaccine Manufacture, QA and Total Quality Management Programs, Manufacturing and Quality Systems, FDA/EU/PIC/S GMP compliance audits and GMP facility design and validation.
Tony is a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA), conducting GMP licencing audits on behalf of the Australian Government.
Tony was a founding Partner of SeerPharma and remains a Mentor after stepping down from the Partnership as he heads towards retirement.