Andrew Giles Profile
ANDREW GILES
Partner & 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.

David Spaulding Profile Photo
DAVID SPAULDING
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.

Ian Lucas Profile Photo
IAN LUCAS
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.

Louise White Profile Photo
LOUISE WHITE
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.

Paul Kerr Profile Photo
PAUL KERR
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.

Rohan Bhatia Profile Photo
ROHAN BHATIA
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.