Ignace Vallejo. Ph.D

"You don't have to be great to start, but you have to start to be great" Zig Ziglar. [email protected] 21 years of experience in the Biotech/Pharmaceutical industry in Quality Assurance and Quality Control with extensive regulatory requirement knowledge Conducted Product Investigations Pharmacovigilance Inspection of all product packaging to determine a non-negative product impact Conducted both internal and external audits Conducted monthly GCP training for all new Employees regardless of position Delivered 100%, on time and before due date all reviews and releases of batch records Initiated changes to S.O.P.'s to ensure compliance with all GCP's 10 years of experience conducting GCP audits CROs & Vendors Multiple European audits including France & Russia AREAS OF EXPERTISE Fluent in Spanish, French, Italian and Portuguese Knowledge of GCP, cGMP, GLP, GXP requirements Certified Risk Management and Six Sigma "Black Belt" Certified Quality Auditor GMP Internal and external Audits International audit experience: UK. France, Spain, Italy, Japan and Germany National Audits: MA, CT, NJ, California, etc. Release of Raw Material. Batch reviews and release Medical/Scientific Writing QA/QC TrackWise and LIMS system Risk assessment, root cause, exception reports, CAPAs, deviation reports, investigation analysis and non conformance 21 CFR part 211 guidelines