About me
Accomplished Quality Professional with a broad background in pharmaceutical life sciences having R&D through commercial experience with 25 years of practice in Quality & Manufacturing, global consulting, and business development. Experienced and well versed in GMP and have working knowledge of GCP/GLP frameworks for FDA/EU regulations and guidelines. Experienced in Deviation/CAPA Management, Change Management, SOP development, Vendor Oversight and Quality Auditing, Regulatory Inspection Readiness, QMS development and implementation, Training, CMC documentation review and product disposition. Other areas of experience include Product Complaint investigations, APR/PQR, Quality metrics compilation and reporting.
