Roger has a strong track record of delivering sustainable performance in international pharmaceutical quality assurance.
His core competencies include: EU Qualified Person, routinely certifying generic finished product from Indian production sites, Risk based and compliance auditing of API and secondary manufacturing facilities to ICHQ7 and GMP. Regulatory inspection preparation for FDA PAI and MHRA inspections. Assessment of, and improvements to, QMS and QRM Effective management of deviations through RCA and CAPA. Increasing GMP expertise through training and publication of topical articles.
Rogers achievements include: Preparing strategically important sites for successful inspections. Delivering high quality audits in Europe, USA, India and China with associated VP stakeholder engagement. Coaching both auditors and auditees to improve handling findings, recommendations and corrective actions
Roger has a BSc (Hons.) in Applied Chemistry,
He lives in the UK