Consultant, Pharmaceutical Services

Country: South Africa

Sheila Shadbolt is an experienced quality professional with over 15 years’ experience in the pharmaceutical manufacturing environment in technical and quality leadership roles in both quality assurance and quality control. She has provided strategic leadership of quality organizations and GMP laboratory operations. She has practical experience of development and implementation of quality management systems in Lean/Six Sigma manufacturing environments.

Ms. Shadbolt has supported a large API facility and manufacturing operations of both human and veterinary products within parenteral, non-sterile liquid, vaccines and biological product manufacture.

She is eligible to act as a QP via the permanent provisions of 2001/83/EC and has also acted as Responsible Person. She has broad knowledge and understanding of pharmaceutical production, plant design and operation.

Ms. Shadbolt has extensive experience of worldwide regulatory agency GMP/GDP expectations and current knowledge and understanding of regulatory requirements for medicinal product development, manufacture and distribution of API and licensed medicinal products. She has a BSc in molecular biology and an MSc in chemistry.

Her areas of expertise include:

  • Vaccines and biological product manufacture
  • Sterile and aseptic manufacture
  • GMP auditing of facilities and processes
  • Quality management systems
  • Supply chain assurance