Dynamic professional in the Electronic, Pharmaceutical Manufacturing Industry and Consulting Services with proven experience in computerized system validation (CSV), manufacturing execution systems (MES), documentation control system (COSMOS), quality management systems (TrackWise), ERP business control systems (SAP) security and administration in pharmaceutical environment and ECC SAP Security and administration in aerospace industry. Certified Computer System Validation Specialist. Certified Quality Auditor by ASQ. Focused on Quality, Internal Controls and Current Good Manufacturing Practices (cGMP) to comply with regulatory controls by the Food and Drug Administration (FDA), Sarbanes-Oxley (SOX) , and Medicine Health-Care Regulatory Agency (MHRA).
Axon Pr
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Sap Security AnalystAxon Pr Jun 2010 - PresentAxon Pr, Isabela, PrAs SAP Security Analyst contractor, I support the SAP ECC 6.0 Security for Pratt & Whitney (PW) Company for all SAP Production, Quality and Development systems. Create, modify and/or delete SAP accounts, password reset, Composite and Single Roles creation and modification and SAP security support to PW users based on GSM Helpdesk Ticket Requests assigned to Axon PR within an established Service Level Agreement (SLA).
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Csv & Sap Distributed Security Liaison (Dsl)Bristol-Myers Squibb Manufacturing Company May 2003 - Nov 2008Bristol-Myers Squibb Manufacturing CompanySAP Distributed Security Liaison (DSL)• Administer the enterprise resource planning (ERP) SAP 4.6 and SAP ECC 6.0 versions business system Users Accounts and Security at BMS Mayaguez site.• Approve SAP users accounts creation based on Activity Group assignment for a job function. • Perform SAP Users Access Review three (3) times per year for segregation of duties, user accounts 90 Day Inactivity and validity date on Temporary or Consultant Employees.• Monitor Segregation of… Show more SAP Distributed Security Liaison (DSL)• Administer the enterprise resource planning (ERP) SAP 4.6 and SAP ECC 6.0 versions business system Users Accounts and Security at BMS Mayaguez site.• Approve SAP users accounts creation based on Activity Group assignment for a job function. • Perform SAP Users Access Review three (3) times per year for segregation of duties, user accounts 90 Day Inactivity and validity date on Temporary or Consultant Employees.• Monitor Segregation of Duties and ensure mitigating controls are in place to control segregation of duties conflicts to comply with SOX Act and BMS Internal Controls regulations. • Support for compliance in BMS Corporate, SOX and FDA Audits.Computer System Validation (CSV) Specialist • Develop Computer System Validation (CSV) documentation: Validation Plans, Validation Protocols, Traceability Matrix, and Validation Reports to complete Systems Development Life Cycle (SDLC). • Support and/or perform CSV qualification (IQ, OQ, PQ) protocols on SAP, Trackwise, COSMOS and Computer Integrated Manufacturing System (CIMS). • Perform annual Security Risk Assessment revision for Manufacturing Execution System. • Conduct Systems Periodic Reviews for CSV systems to maintain their validated state.• Perform validated computerized systems retirement (decommissioning) activities. Show less
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Cims (Computer Integrated Manufacturing System) AdministratorBristol-Myers Squibb Manufacturing Company Jan 1995 - Nov 2008Bristol-Myers Squibb Manufacturing CompanyCIMS (Computer Integrated Manufacturing System) Administrator • Administer Users Accounts and Security in an OpenVMS 7.1 Operating System for the CIMS Network. • Administer and maintain of the warehouse database (DBA) using Oracle Rdb7. • Perform system maintenance and recovery procedures for the 6 ALPHAservers CIMS network system. • Analyze discrepancies and propose corrective actions between CIMS Manufacturing computer system, SAP Business computer… Show more CIMS (Computer Integrated Manufacturing System) Administrator • Administer Users Accounts and Security in an OpenVMS 7.1 Operating System for the CIMS Network. • Administer and maintain of the warehouse database (DBA) using Oracle Rdb7. • Perform system maintenance and recovery procedures for the 6 ALPHAservers CIMS network system. • Analyze discrepancies and propose corrective actions between CIMS Manufacturing computer system, SAP Business computer system and Quality Assurance (QCMain) system. • Develop, implement and train on Standard Operating Procedures for computerized system options for users to comply with cGMP’s. • Complete documentation on assigned Corrective Action/Preventive Action (CAPA), Quality Events or QC Evaluation incidents in the TrackWise Quality Management system.• Support BMS Mayaguez site in BMS Corporate, SOX, MHRA and FDA Audits. • Support Finance Department during bi-annual physical inventory reconciliations.• Supervise CIMS Console Operators, coordinate vacations and working shifts coverage and approve employee’s time cards in KRONOS system. Show less
Luis Vargas Skills
Luis Vargas Education Details
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Interamerican University, San Germán CampusCum Laude -
Universidad De Puerto RicoMathematics - Computer Programming
Frequently Asked Questions about Luis Vargas
What company does Luis Vargas work for?
Luis Vargas works for Axon Pr
What is Luis Vargas's role at the current company?
Luis Vargas's current role is SAP Security Analyst at Axon PR.
What schools did Luis Vargas attend?
Luis Vargas attended Interamerican University, San Germán Campus, Universidad De Puerto Rico.
What skills is Luis Vargas known for?
Luis Vargas has skills like Sap R/3, Sap Implementation, Sap Bw, Sap Erp, Sap Netweaver, Csv, Capa, Cosmos, Mes, Trackwise, Kronos, Sap 4.6.
Not the Luis Vargas you were looking for?
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Luis Vargas
B.A. Investigación Criminal / M.S.S En Ciencias Sociales En Criminologíadepartamento De Ciencias De La Conducta Y Asuntos De La ComunidadMayaguez -
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Luis Vargas
Strategic Leader | Experienced Technical Program Manager | Driving Innovation & Excellence In Cross-Functional Teams | Proven Leadership In Complex Technical InitiativesAguadilla -
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