Consultant, Pharma Biotech

Email: pharmamail@nsf.org
Phone: +44(0)1751 432999
Country: United Kingdom

Susan Rocca has nearly 40 years of experience in the pharmaceutical industry. She is a chemist who has held senior quality assurance roles with GlaxoSmithKline and chemical companies.  She provides cGMP audits, training and consulting.

Her site roles included qualification of a new purified water system, design of a new archive building, redesign of a suite of laboratories to incorporate smart instrumentation and day-to-day quality management and inspection preparation.

Head office roles included quality strategy development, interaction with commercial companies across the world, supply chain management, distribution quality risk management and cold/cool chain quality issue management.

Her areas of expertise include:

  • Active pharmaceutical manufacturing: Complying with cGMP requirements
  • Auditing for APIs, distribution and cold chain, and good laboratory practice
  • Incident management: Troubleshooting and problem solving to root cause.  Rapid response to global quality issues.
  • Quality management systems: Development through simplification
  • Quality leadership: promoting that quality makes sense for a better business and helping quality departments integrate their plans with site business plans
  • Application of Lean Sigma tools to reduce errors and continuously improve processes
  • Application of quality procedures to non-manufacturing areas: logistics, commercial operations and regulatory processes
  • Inspection preparation, including one-on-one preparation clinics
  • Group training and one-on-one coaching for quality management understanding and application
  • Cold/cool chain processes for quality assurance
  • Preparation of sites for FDA, MHRA and other agency inspections, with successful outcomes
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