Jenni NewcombeJenni has 27 years’ experience in the Pharmaceutical industry, 8 in Quality Control and the remainder in Quality Assurance whilst working as a senior quality professional in a high volume fast paced global Generic environment. Currently acting as a Qualified Person and a Responsible Person, she has extensive experience in GMP and GDP.

Jenni has considerable experience in the maintenance and ongoing improvement of Pharmaceutical Quality Systems in Manufacturing/Packing operations including in house and third party, and commercial supplier quality.

She has been the Quality Lead on integration/divestment activities and helped transition through a number of acquisitions/mergers ensuring both GMP and GDP commitments are met. Previously seconded to sites in the Netherlands, Ireland and in the US, Jenni has helped improve GMP standards, support deviation close out and support readiness activities ahead of regulatory inspections.

Jenni achieved a First class BSc (Hons) in Applied Chemistry in 2004 and is trained as a Lean Six Sigma Green Belt. She became eligible to act as a Qualified Person in January 2007 and is currently working as the of Director Supplier Quality, Qualified Person/Responsible Person for Accord-UK Ltd (formerly Actavis UK Ltd) based in Barnstaple, N. Devon. She is responsible for UK and EU Quality teams with oversight of Contract Manufacturers/Suppliers/Service providers, the Corporate Audit team, Good Distribution Practice (GDP) policy across Europe, Middle East and North Africa, and Artwork quality related processes.

Jenni delivers training courses for RSSL on an independent basis.

 

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