Accomplished Quality Professional with a broad background in Pharmaceutical Life Sciences having R&D and commercial (sterile/non-sterile) experience with 22+ years of practice. Experience in Deviation/CAPA Management and Change Control, SOP development with use of accelerators and advanced mapping skills, Product Complaint investigations, APR/PQR compilation and reporting, controlled document retention, revision and issuance batch record review/product release, training and client/agency audits. Well versed in cGMP knowledge, FDA/EU regulations and guidelines and experienced in Documentum, TrackWise and Veeva Vault systems.