Dr Ghulam Shabir has 35+ years experience in the pharmaceutical and biotechnology industry including Abbott Laboratories, Bristol Laboratories, Norbrook Laboratories, LGC and GSK (GlaxoSmithKline) UK.
He is a highly skilled in all aspects of Quality & Compliance, preparing pharmaceutical industry, leading and hosting regulatory audits (GMP/GDP EU GMP V4/MHRA, FDA, ICH, WHO, ISO 13485, ISO 9001:2015). He has strong technical knowledge of a wide range of pharmaceutical manufacturing, testing, packing and compliance processes. Wide experience of setting up new GMP pharmaceutical manufacturing facilities, implementation of QMS from scratch, qualification / validation of facilities, utilities, production and laboratory equipment, submission of MHRA application for new Manufacturer’s / Importer’s licence (MIA) and preparing the site for first successful regulatory inspection for registration and GMP licence. Evaluation of API suppliers, CMOs, contract analytical laboratories, audits, technical /quality agreements and approvals.
Dr Shabir is a certified Lean Six Sigma Green Belt, IRCA qualified pharmaceutical lead auditor and skilled in driving continuous improvements to strive for excellence in all aspects of the pharmaceutical business including commercial acumen.
Dr Shabir has received several awards including Gold Award from GSK UK and Abbott Laboratories UK in recognitions for performance, technical, innovation and quality & compliance excellence.
Dr Shabir is trained and qualified professional in the field of healthcare for pharmaceutical and medical devices FDA Quality System Regulations (QSR) by the world class Institute, Association for the Advancement of Medical Instrumentation (USA).
Dr Shabir has authored over 60 awards winning and top cited Articles, published in various international high impact journals and author of 3 modern analytical chemistry Books. He also has presented many posters/papers/lectures at national (UK) and international conferences worldwide. He is a member of editorial advisory board for various international journals including American Pharmaceutical Review since 2004.
BSc (Hons) & MSc in Chemistry
PhD in Chemistry, University of Sunderland, UK
Postdoctoral Fellowship & Visiting Professor, Oxford Brookes University
Post Graduate Diploma in Pharmaceutical Analysis specializing in Quality Management, University of Strathclyde Glasgow, Scotland
Management of R&D Projects Skills Certificate, University of Oxford
Higher Management and Quality Assurance Role Certificate, Glasgow Caledonian University
BTECH Diploma in Analytical Chemistry, University of Greenwich, London
Chartered Chemist (CChem) of the Royal Society of Chemistry UK
Fellow (FRSC) of the Royal Society of Chemistry UK
Chartered Scientist (CSci), Science Council UK
Fellow and Chartered Quality Professional (FCQI CQP) of the Chartered Quality Institute London
IRCA Lead Auditor
Lean Six Sigma Green Belt Certified