Qualified Person (QP) Woking, Surrey, GU22 7BB, UK
Pharmacist with more than 25 years of experience in the Pharmaceutical Industry and QP (EU-QK and UK-QP) from 2001, for all dosage forms (i.e., solid/liquid/semi-solid nonsterile/sterile, small molecules/biotechnological, Commercial Products and IMPs for Clinical Trials, Human/ Veterinary). Experienced in Production, Quality Control, and Implementation and Management of Pharmaceutical Quality Systems (PQS). Subject Matter Expert (SME) in QMS, Quality & Compliance with GxP (GMP/GDP/GCP), Auditing, Gap Analysis, Process Improvement, Management of Deviation and CAPA, Risk Management, Root-Cause Analysis, Lean SixSigma tools, Implementation and monitoring of Remediation Plans and Management of Third Parties. Also experienced in Pharmaceutical Development (using QbD (Design of Experiments (DoE) and Minitab v17) (ICH Q8(R2)), Statistics, Technology Transfer, Validation of Processes and of Analytical Methods and Intellectual Property.