 Over14 years of in-depth experience in the pharmaceutical industry.
 Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes.
 Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches.
 Innovative problem-solver who can generate workable solutions and resolve complaints.
 Flexible team player who thrives in environments requiring ability to effectively prioritize and juggle multiple projects.
 Effective organizational, written communication, and reading comprehension skills.
 Assist with execution of protocols.
 Bilingual in Spanish.
 (BPLM) Baxter Product Lifecycle Management, (EQMS) Enterprise Quality Management Solution TrackWise, (JDE) Edwards EnterpriseOne.
 EPA QA/G-6 Standard Operating Procedure (SOP).
 US FDA Title 21 CFR Part 820 Quality Systems Regulation.
 US FDA Title 21 CFR Part 11 Part 11 Electronic Records, Electronic Signatures.
 US FDA Title 21 CFR Parts 210/211 Good Manufacturing Practices.
 21 CFR Parts 210/211 Drug GMPs.
 21 CFR Part 820 Device GMPs.
 ICH Q7 - GMPs for Active Pharmaceutical Ingredients.
 Change Management (ERP).
 International Organization for Standardization (ISO).
 Validation of Process and System.
 Hazard Analysis and Critical Control Points (HACCP).
Description
