Director / Senior Consultant
Andrew has over 30 years of experience in the pharmaceutical industry including more than 11 years as a Medicines Inspector with the Therapeutic Goods Administration (TGA) of Australia. During his time with the TGA Andrew was lead inspector for initial, routine and special inspections of Australian and international facilities that produced sterile and non-sterile medicines as prescription medicines, Over The Counter (OTC) medicines, complimentary medicines, sunscreens, veterinary products and Active Pharmaceutical Ingredients (API). Andrew has had experience in dosage forms including injectable, biologicals, radiopharmaceuticals, compounding, oral dosage forms and sprays. Andrew has also worked with inspectors from other agencies and been part of, and lead for, multinational inspection teams.
Director / General Manager (Asia)
Biju has over 20 years of commercial experience in the life science industry. He has worked with leading European and US multinational manufacturers of life science automation/robotic platforms, helping them drive sustainable profitable business growth in Australia and New Zealand. Since 2014, Biju has overseen SeerPharma’s Sales and Marketing efforts bringing in best practices learnt from managing complex B2B deals and transactions. Biju is also responsible for SeerPharma’s activities in Asia, with full P/L responsibility for SeerPharma (Singapore). Biju holds an MBA from Monash University, a Bachelor of Electrical/Electronic Engineering (with Honours) and a Bachelor of Science majoring in Physiology from the University of Western Australia. Biju completed his Honours in Biomedical Engineering on full scholarship at the Karlsruhe Institute of Technology (KIT) in Germany. He is a member of the Australian Institute of Company Directors (MAICD).
Director / Customer Solutions Business Manager / Training 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.
Director / 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.
Director / General Manager (Australia)
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.
Director / Software Products and Services Manager
Rohan leads SeerPharma’s Software Products and Services team. In this role, he oversees the MasterControl business unit at SeerPharma. He has 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 delivering projects that meet and exceed customer expectations. Since 2016, Rohan’s team at SeerPharma has deployed MasterControl to over 70 pharmaceutical and medical device manufacturers across the APAC region. Helping our clients digitise their Quality and Manufacturing workflows, utilising tools from MasterControl, the eQMS platform used internally by the US FDA.