MES Pas-X, UAT, High Sheer Granulator, Processes, HPLC Instrument, TOC & GC, Spectroscopy, TOC Instrument, Equipment Validation –Wyeth Pharmaceutical Guayama, Merck, Las Piedras. Ability to work in teams. Knowledge in the following ERP system: MES Pas-X, SAP FI, PP, MM, Explorer, SDLC. Computer languages: RPG400, RPGLE, Java, Access, COBOL, Foxpro, MS SQL, Visual Basic, MAPICS, JD Edward. Operating Systems: Novel, AS400, Windows Server 2003 & Windows NT. Systems Utilities: MS Office, Visio, MS Project, Bar Code programming experience. Certified in Fundamentals of Biotechnology Manufacturing. Training in GMP, Computer Systems Validation (CSV- SDLC,IQ,PQ,OQ) and 21 CFR Part 11 Electronic Record & Electronic Signature Courses of Business Administrations: Accounting, IS Management, Statistics, Economy Validation on: CSV, Facilities, Utilities, Packaging, including: Manufacturing Equipment: OPC Server, Coater Tablet Accelacota, Hi Sheer Granulator, IBC Washer Portable sieve, low head room hoist, Down Flow Booth, Drum Tipper, Ultrasonic Washer, Vacuum transfer system, Suspension Tanks, Deduster and Metal Checker, Tablet Film Coater, portable Peristaltic pumps, and Cleaning. QBMS, SAP FI: General Ledger, Account Payable, Account Receivable, SAP PP, MM and Explorer Modules. MES Pas-X MOs generation, process recipe development, equipment setting and material SAP interfaces. CSV Assessments for Manufacturing Equipment at Cordis LLC. This included the revision of existing Validation Protocols in order to find opportunities and remedies for them. Risk Assessments, Test Scripts, Traceability Matrixes and System Requirements were developed during remedies exercises. Systems software: Temp Tale Manager, Spray Coat System, Empower and Data Net Supervisor. Work in Schering Plough Pharmaceutical with the validation of lab Instruments. Understanding of how to conducts: SDS Page, Buffer preparation, ELISA & Concentration determination.
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Mes Validation SpecialisBbraun Dec 2022 - Mar 2023United StatesMES Rockwell Pharma Suit Validation Activities. IQ, OQ, Closing Reports. Work Instructions. -
Mes DesignerMerck Aug 2021 - Mar 2022Elkton, Virginia Trouble shutting during different biotechnology manufacturing activities operations in the Implementation of Werum Pas X MES. The biotechnology manufacturing process included the following rooms operations: Buffers preparation, Columns, Yeast Harvest, Fermentations and Bioreactors. Providing MES operations support during manufacturing biotechnology productions process in their aseptic rooms of different buildings. System support assistance with equipment like scales, bins, containers, scanners and other miscellaneous equipment during the productions process activities. -
Validation ScientistBristol-Myers Squibb Sep 2018 - Feb 2019Humacao, Puerto RicoPreparing CSV Qualification Protocols and System Operating Procedure for AXIMA Confidence IR Mass Spectrometer with AXIMA ID PLUS Microbial identification instrument. Developing validation deliverable: Risk Assessment, URS, SDS, FDS, IOQ, PQ and protocols executions. -
Senior ScientistAvara Pharmaceutical Services Jan 2018 - Mar 2018AreciboPreparing Qualifications Protocols and Systems Operating Procedures for manufacturing equipment as Kason Drum Sifter, Kason Vibroscreen Separator, Quadro Comil Mills, Drum Lifter, and Glatt Dryer. -
Fema InspectorWsp Inspector Services Nov 2017 - Jan 2018Hato Rey, Puerto RicoInspecting affected infrastructures by hurricanes Irma and Maria. Inspected damages homes of hurricanes victims in Puerto Rico, visiting FEMA applicants in different towns, evaluated and documented dwellings damages
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Validation SpecialistZimmer Biomet Jun 2016 - Sep 2016Ponce, Pr, Puerto RicoValidation Specialist Medical Device CSV qualification at Zimmer Biomet, Ponce. Included Pre-qualification protocols, IQ, OQ and PQ protocols generations and execution for Manufacturing Equipment Software. -
Senior Regulatory ConsultantThe Janssen Pharmaceutical Companies Of Johnson & Johnson Apr 2015 - Dec 2015Gurabo, Pr, Puerto RicoSpreadsheet Validation that included the Risk Assessment, System Design Specification, Traceability Matrix, IQ, OQ and PQ deliverables generation. Execution of the Qualifications Protocols for laboratory spreadsheet. -
Regulatory Compliance ProfessionalMerck Mar 2013 - Jan 2014Merck Las PiedrasCommissioning and Qualification activities -
Regulatory Compliance SpecialistMcneil Consumer Healthcare Mar 2010 - Feb 2012 Developed Risk Assessment, User Requirements Specifications(URS) and IOQ Protocol for Manufacturing Area potable water heater at Novartis Pharmaceutical, Humacao site. Develop User Acceptance Test (UAT) activities at McNeil Pharmaceutical, Las Piedras site. Prepare UAT deliverables for CSV manufacturing processes. Prepare Pas-X successful Process recipes designs for Granulation, Solutions, Compression, Coating, and Packaging in order to elaborate main critical process segments needed to be included in the CSV Test Scripts for validation. Tested critical manufacturing processes as material Holding Time, Timers, Bulk Consumption, Stock Creation, Identity Check, Yield determination, Label printing, and clean equipment availability. Work with SAP and Pas X interfaces. Perform dry runs, execute UAT protocol and prepared Final Reports. MES Werum PAS-X MOs generation, process recipe development, equipment setting and material SAP interfaces, Relational Databases, MS SQL. Working CSV assessments for Packaging and Manufacturing Systems during McNeil Work Plan remediation activities. Audit all CSV documents for Neckbanders, QC System, Induction Sealer, Bowl Charger Tanks, Coating Solution Tanks, GelCap and GelTab systems. Peraparing assessments documentation and Remediation Plan. Working in the Verification activities for Bulk Bags & KCL equipments during a product transference project at Pfizer, Guayama. Working in the execution activities for Implementation Verifications (IV) and Operational Verifications (OV) protocols in Weighing and Dispensing Manufacturing Area. Preparing closing ISARR reports. -
Validation Engineer At Wyeth (Guayama Pharmaceutical Site)Wyeth Biopharma Jul 2006 - Nov 2007 Commissioning projects activities at Wyeth Pharmaceutical, Guayama site. Include commissioning and qualification project activities developing and executing of SAT, IOQ protocols for QBMS(Quality Building Management System). Perform Utilities test in order to develop facilities validations deliverables. Developing and executing of OPC Server and IBC Girton Washer commissioning protocols, IQ and OQ. Execute cleaning activities and PLC testing. Also commissioning execution for the High Sheer CDR, GTR, etc) or field testing. -
Validation ConsultantShering Plaugh Pharmaceutical Jun 2004 - Feb 2006Schering Plough - Participated in validation of the ONIC FT-IR laboratory equipment application software as part of their Part 11 remedies plan. Responsible in developing of software administration SOPs, runs protocols dry runs and its executions. Cordis - Working in the TempTale manager, Spray Coating System, Data Net Supervisor and Spreadsheets. These included Systems Assessments, Protocols generations, SOPs and all deliverables required. Worked with MS Project Management.
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Programmer/System Analyst Rpg-As400Eaton Corporation 1995 - 2002Responsible of application’s developing projects in the AS400 system. Worked with QUERIES, DFU, SDA, RLU, PDM, CL & RPGLE. Worked with the analysis, design, programming, systems documentation including system validation, implementation and maintenance of these projects. Provide supports to users with AS400 applications including MAPICS, Windows Server 2000 and Windows NT. Work with the MAPICS Inventory Management system implementation.
Maritza C. Education Details
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Systems Information Management -
Industry Biotechnology Technics -
Computational Mathematics
Frequently Asked Questions about Maritza C.
What is Maritza C.'s role at the current company?
Maritza C.'s current role is Validation Consultant.
What schools did Maritza C. attend?
Maritza C. attended Universidad Del Sagrado Corazón, Universidad De Puerto Rico, Universidad De Puerto Rico.
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Maritza C.
Durham, Nc -
4msn.com, mrcg.org, mrcg.org, mrcg.org
1 +130544XXXXX
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2marshalls.com, msn.com
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