An NSF International Company Mrs Susan Rocca
Consultant
BSc (Hons)
- [email protected]
- +44(0)1751 432999
Susan is a Chemist who has held senior QA roles with fine chemical companies and latterly with GlaxoSmithKline.
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, plus 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.
Areas of Expertise
- Active pharmaceutical manufacturing: complying with cGMP requirements
- Experienced auditor for APIs, distribution and cold chain, in the UK, Europe, India, Singapore, Dubai, Mexico, Panama, Costa Rica, Puerto Rico and the USA
- Auditing specialisation in good laboratory practice, distribution and cold chain
- 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: eg logistics, commercial operations and regulatory processes
- Inspection preparation, including one-to-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
