Maritza C. Email & Phone Number

United States

MES Rockwell Pharma Suit Validation Activities. IQ, OQ, Closing Reports. Work Instructions.

Elkton, 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.

Humacao, Puerto Rico

Preparing 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.

Arecibo

Preparing Qualifications Protocols and Systems Operating Procedures for manufacturing equipment as Kason Drum Sifter, Kason Vibroscreen Separator, Quadro Comil Mills, Drum Lifter, and Glatt Dryer.

Hato Rey, Puerto Rico

Inspecting 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

Ponce, Pr, Puerto Rico

Validation 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.

Gurabo, Pr, Puerto Rico

Spreadsheet 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.

Merck Las Piedras

Commissioning and Qualification activities

 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.

 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.

Schering 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.

Responsible 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.

Mba -, Systems Information Management

Certificaiton, Industry Biotechnology Technics

Bs, Computational Mathematics