Dr Ghulam Shabir is:

A versatile and a Senior Quality Executive with 35+ years of experience driving operational excellence in the pharmaceutical manufacturing & healthcare sectors. 

Proven track record leading Six Sigma projects that cut defects and improved process throughput significantly and saving millions of US dollars.

Skilled in design and implement quality management systems (QMS) aligned with EU/MHRA, FDA and ISO 9001 regulatory compliance, large cross-functional team leadership, and supplier quality management.

Experience in variety of dosage forms including biologics, biotech, sterile and non-sterile liquid and oral solid dose products for commercial in human use and clinical trial supply.

Significant experience in setting up new quality systems from scratch and driving continuous improvements to strive for operational excellence in all aspects of the pharmaceutical business.

Experience in hosting and leading regulatory inspections (MHRA, FDA and other regulatory bodies) and preparing pharmaceutical industries for GMP inspection readiness.

Proven experience in pharmaceutical analysis, analytical development, leading & managing large QA, QC & R&D multicultural teams, pharmaceutical quality systems, batch release governance, deviation, change control management, and technical investigations.

Recognised for developing talent, mentoring senior leaders, and inspiring teams to deliver customer-centric, measurable outcomes at pace. With a collaborative, analytical, and commercially focused approach to strategic leadership and characterized by integrity and a commitment to excellence.

Certified Lean Six Sigma Green Belt - Accredited by Abbott Laboratories and Lead Auditor - CQI-IRCA

PhD in Chemistry, University of Sunderland UK

Fellow, Chartered Scientist and Chartered Chemist of the Royal Society of Chemistry

Fellow and Chartered Quality Professional of the Chartered Quality Institute London

Multiple awards winning industrial & academic scientist/QA professional including Gold Awards in recognitions for high achiever, technical, innovation, quality and operational excellence.

Author of over 60 top cited and most read awards winning Articles, published in various international high impact journals and author of 3 modern analytical chemistry Books.

Top Skills

• Pharmaceutical QA, QC and analytical development • Six sigma & lean methodologies • Risk management & mitigation • Regulatory compliance (ISO 9001, EU/MHRA, FDA, GMP) • Root cause analysis, CAPA & excellence in deviations management • Supplier quality management • Audit management • Change management & organisational development • Operational excellence & cost optimisation • Digital transformation strategy • Cross-functional team leadership & cultural integration • Continuous improvement • GMP compliance strategy and audit readiness  • QMS design, implementation, gap analysis and remediation • Technical training and executive coaching • Interim QA and QC services

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