Description
Summary of Qualification Electrical Engineer with broad experience in the Electronic, Electro Mechanic and Pharmaceutical Industries. Green Belt and ASQ-CQE Certified, Black Belt Trained. Strong knowledge on CFR, Aseptic Pharmaceutical Manufacturing Process and cGMP. Managed major document types as Annual Product Quality reports (APQRs), Master Batch Records (MBRs), Standard Operational Procedure (SOPs), Stability Studies and Plant Record Management Program. Lead the deployment of Enterprise applications and Corporate Policies due to a Consent Decree. Experience during the closing, product transfer and startup of a manufacturing plant. Lead internal audits and participation in regulatory inspections war room. Oriented toward process consolidation. Site Change Control Committee member. Experience in Non-Conformance and CAPA. Lead quality, financial and business key metrics indicators collection and report. Knowledge of Enterprise applications as SAP, Trackwise. Computer proficient. Bilingual in English and Spanish. Accomplishments * Successfully managed the Corporate Policies and Guidelines and Risk Assessment deployment. * Annual Product Quality reports (APQR) completed on time - no observation from any regulatory agency. * Maintained zero SOPs biennial revision due - previously over 200 documents overdue. * Guided the SOPs migration process in a timely schedule within budget (from manual to electronic system). * Lead internal audits as per company's schedule, active participation on regulatory inspections war room - FDA, ANVISA and MHRA. Successful ISO 9000 registration. * Successfully implemented the Electronic Master Batch Record (ebr) and MES application. * Lead the fabrication consolidation project, executed on time with savings over $300K per year. * Increased breakers calibration yield from 60% to 80%. * Quality and Excellence Recognition - Best Practice Award. * Awarded with GE Stock Options - Recognition program and GE Bronze Medallion - Invention Program. Accomplishments * Successfully managed the Corporate Policies and Guidelines and Risk Assessment deployment. * Annual Product Quality reports (APQR) completed on time - no observation from any regulatory agency. * Maintained zero SOPs biennial revision due - previously over 200 documents overdue. * Guided the SOPs migration process in a timely schedule within budget (from manual to electronic system). * Lead internal audits as per company's schedule, active participation on regulatory inspections war room - FDA, ANVISA and MHRA. Successful ISO 9000 registration. * Successfully implemented the Electronic Master Batch Record (ebr) and MES application. * Lead the fabrication consolidation project, executed on time with savings over $300K per year. * Increased breakers calibration yield from 60% to 80%. * Quality and Excellence Recognition - Best Practice Award. * Awarded with GE Stock Options - Recognition program and GE Bronze Medallion - Invention Program.
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