Alexis Pagan Email & Phone Number

Louisville, Ky, Us

United States

Louisville, Kentucky

Provide validation services at Amgen Louisville Distribution Center (Louisville KY) and AstraZeneca (Indiana).

Provide services to Pfizer Pharmaceuticals as SNS Transfer Project Lead.

Services provided to Pfizer, Puerto Rico:•Periodic Review for the Application and Infrastructure of the Building Management System (BMS) Data Historian, Calibration management System (CALMAN) and the Manufacturing Execution System (MES) PMX Tygacil in Pfizer Pharmaceuticals, Carolina Site, PR.•Periodic Review for the Application and Infrastructure of the Agilent OpenLab Data Archive System and the GE Proficy Data Historian in Pfizer Pharmaceuticals, Guayama Pharma and Consumer Sites, PR.•Development of the Retirement Plan for Kronos System in the Pfizer (L-Wyeth) Guayama, Carolina and San Juan sites and centralization in the Vega Baja Site.•Support in the qualification documents review for MES in the Pfizer Pharmaceuticals, Pharma and Consumer Plants, Guayama and Carolina Site.

Services provided to Wyeth, Puerto Rico:•Development and Execution of the User and Functional Requirements, Validation Plan, Risk Analysis, Regulatory Assessment, Traceability Matrix, IQ/OQ/PQ protocols, IQ/OQ/PQ Summary Reports and Validation Plan Summary Report for Training Information Management System (TIMS) installed on Wyeth Pharmaceuticals, Guayama and Carolina Sites, PR.•Support in the qualification documents review for MES in the Wyeth Pharmaceuticals, Pharma and Consumer Plants, Guayama P.R.•Periodic Revier for the Local Area Network Switches (Server Switches, Core Switches, Distribution Switches, Plant Switches) and the Wireless Infrastructure at Wyeth Pharmaceuticals, Guayama Site, PR•Periodic Review for the Application and Infrastructure of QALASS, EMSS, Product Batch Records, MIR, BMS Data Historian, PCS, Foxboro, Honeywell Monitoring, GPS, Turbochrome, MES, Laces CDAS, Laces DA, Laces LIMS, SQL LIMS, GxPharma systems in Wyeth Pharmaceuticals, Carolina Site, PR.•Support in the MES EBRs Qualifications and documentation review.•Development of migration data protocols for CCure and Kronos Workforce applications to New Storage Area Network (SAN).•Support in the DART system upgrade qualification.•New Computer System Validation Lifecycle Policy Implementation.•Development of Traceability Matrix for IsoTrain, LACES (LIMS, DA & CDAS), Trackwise Computer Systems.•Support in the Harmonization for the Computer System Validation SOPs with the New Computer System Lifecycle Policy.•Support in the New Computer System Validation Lifecycle Policy Trainings.•Support in the MES OQ protocol execution.

Services provided to Pfizer Pharmaceuticals:•Development and execution of IQ/OQ Computer Validation Protocol for a Dr. Schleuniger AT4 Tablet Tester.•Development of the Validation Plan, User Requirements and Design and Functional Specification for a Dr. Schleuniger AT4 Tablet Tester.•Development the Traceability Matrix and the Impact Assessment for a Dr. Schleuniger AT4 Tablet Tester.•Execution of IQ/OQ protocol for a Autoproof Pro Electric Proof-Reading System.•Execution of IQ/OQ protocol for MAPS 6.2 Dispensing Area.•Development and execution of IQ/OQ Computer Validation Protocol for a Tote Bin Washer System.•Development and execution of IQ/OQ Computer Validation Protocol for a Harro Höfliger Powder Filling Machine for Zitromax product.•Development the Traceability Matrix and the Impact Assessment for the Harro Höflinger Powder Filling Machine using for Zitromax product.•Support actively in the Development of IO/OQ protocol for Korsch XL400 Bi-Layer Tablet Press Machine. •Execution of IO/OQ protocol for Korsch XL400 Bi-Layer Tablet Press Machine. •Audit data for cGMP errors and corrections/veracity. Services provided to Wyeth Pharmaceuticals:•Support in the packaging process for the stability study for Bifeprunox new product.•Development the Master Packaging Records for the different presentations of Bifeprunox.•Development and execution of IQ/OQ Protocols, Summary Reports and Data Pack for PK-Blenders, Lightning Mixers, MG-2 Capsule Fillers, Uhlmann Thermoformers, Uhlmann Cartoner, Cam Cartoner, Aylward Feeder, Laminar Flow Booth, Metal Check, Oscillator Granulator, Tablet Deduster, Visio Systems, Blisters Printers, Air Handling Units, Vibratory Hoppers, Tablets Hoist Feeders, Aylward and Uhlmann Feeders, Air Showers as part of the Validation Master Plan for the legacy equipments. •Execute IQ/OQ, Line Integration and PQ Protocols for the Bottle Packaging Line.