ANDREW GILES
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.
BIJU KISHOR
Director / Commercial and Marketing
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 Commercial and Marketing efforts bringing in best practices learnt from managing complex B2B deals and transactions. Biju also has 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).
DANIEL FLEWELLEN
Director / Consulting Manager
Daniel has over 25 years of broad pharmaceutical and medical device industry experience as a compliance specialist across various technological areas (Scientific and IT). As a Director at SeerPharma, he leads the Consulting arm of the business.
Daniel has extensive experience conducting IT, CSV and DI gap analysis and compliance audits for companies on quality systems and CSV programs. Daniel trains in computer validation (21 CFR Part 11, Annex 11, Data Integrity and GAMP) and assists companies in establishing IT compliance and computer validation programs. He regularly gets involved with specific validation projects in clinical, manufacturing and laboratory environments and has expertise in ISO 13485, IEC 62304 and CFR 820 regulations .
Daniel holds an Honours degree in Applied Sciences (Chemistry) from the University of Tasmania.
IAN LUCAS
Director / 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 Training Department and is exploring applications of various technologies (including VR/AR/AI/Chatbots) to support customer solutions in-line with Industry 4.0. Ian regularly presents training courses and seminars on practical approaches to computerised system validation.
LOUISE WHITE
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.
ROHAN BHATIA
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 85 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.
