Short biography
A Quality Assurance professional with 33 year’s experience in a pharmaceutical GMP environment, primarily in Sterile and Bio pharmaceutical development and manufacture of Commercial and Clinical APIs.
IRCA Qualified Auditor with extensive knowledge in MHRA, FDA, GMP, GXP, GCP, GLP, and ISO regulatory inspections. Designed and managed a successful site Permanent Inspection Readiness System Plan support facility inspections.
Audit credentials, managed and hosted 7 pre Mock Inspections, 4 successful FDA Pre Approval Inspections, 5 successful FDA & MHRA Routine Inspections, and 3 successful Regulatory Inspections conducted by ANISA (Brazil), MFDS (Korean), and TDMDI (Turkish) Regulatory Authorities for commercial licence approval within those licenced markets.
Developed and managed site systems such as Audit Management Programme, Continuous Improvement, Permanent Inspection Readiness, Site Compliance, and Risk Management.