Edwin Alejandro Email & Phone Number

Dorado, PR

Olvega, Spain

Validation of manufacturing equipment and compliance related activities to support the company expansion strategy of their pharmaceutical products into the US market.

Las Piedras, PR / Lancaster, PA

High-level review of in-place/in-use documentation for plant under FDA’s consent decree to ensure compliance with commitment steps. Activities also included on-site follow-up audits to confirm manufacturing operations adhered to corporate guidelines and standard operating procedures.

Gurabo, PR

Review and approval of Validation and Quality Systems related-documentation in Parenteral Manufacturing facility.

Manati, PR

Direct oversight of parenteral manufacturing operations with Isolation Technology and facilities audits to ensure effectiveness of procedures against current practices. Support on investigations resolution and CAPA alignment.

Wilson, NC

Authored and lead Optimization and Process Validation execution for product transfer. Formulation Manufacturing Records (FMRs) evaluation and development using Trackwise system. Generation of FMRs-related standard operating procedures. Assisting in the Investigations and CAPA Management deployment on site.

Dorado, PR

Direct support on system development life cycle documents generation including CSV Assessments, URS, FRS, SDS, Traceability Matrix, IOQ Protocols/Reports and System Procedures for the Accela-Cota Pan Coater Machine using Compu-Coat 6S software in the manufacturing area. Also, FAT/IOQ protocol generation for the Capper Machines MTC-300 and TG-8.

Waco, TX

Direct support on CSV system life cycle documents generation including FAT Report, Risk Assessment, Traceability Matrix, and IOQ Protocols and Reports for the Weiler 640 Blow/Fill/Seal Machine in the aseptic area and IOQ/CIP/SIP for Process/Compounding Tanks.

Manati / Vega Baja, PR

Direct support on CSV system life cycle documents generation including URS, SDS, TRM, IOQ, and SOPs for the BOSCH In-Process Control (IPC) Checkweigher System Vial Filler Machine on the Parenteral Manufacturing Lyophilization Area. Also, protocol addendum generation for the Rolaids Blenders Control System.

Manati, PR

Responsible for the development and approval process of controlled documents on Change Control Management system. Evaluated site procedures to confirm compliance with pre-established corporate Worldwide Quality Standards. Responsible for the strategy development and activities coordination on Equipment Qualification and Critical Support Systems.

Manati, PR / Arecibo, PR / Ann Arbor, MI

Responsible for computerized/PLC automated equipment validation, software installation and back-up and disaster recovery procedures generation. Performed source code reviews, CSV protocols/documentation review, write-up deviations and make all required corrective recommendations. Factory Acceptance Test (FAT) trips for Omega Unscrambler machine; and High.

Las Piedras, PR

Responsible for the issuance and execution of Air Handling Dehumidification Unit and Mix/Dispense Solution Tank computerized system protocols and summary reports. Factory Acceptance Test (FAT) trips (2) for CAM Blister and Cartoner machines

Vega Baja, PR

Developed and executed facilities/utilities/cleaning validation protocols and reports for pharmaceutical company including: Compressed Air, WFI, Nitrogen, Cooling Tower, and Condensate Steam. Validated Equipment and Control System for aseptic filling line including: CRW-1 Washer, Double Tray Loader, AST-6 Sterilizing Tunnel, and ILF 8/4 RS-RP Filler.

San Germán, PR

Responsible for the issuance and execution of equipment and computerized systems protocols (including summary reports) for pharmaceutical companies including: Environmental monitoring/controller (HVAC), Local Control Modules (LCM's), packaging line equipment (Labeler, Unscrambler, Filler, Capper and Electronic Verification System), and KORSCH Tablet Press.

Vega Baja, PR

Performed the issuance and execution of IQ/OQ/PQ computerized system protocols for pharmaceutical companies including: Environmental monitoring/controller (HVAC), Coating Pan machines, and Cartoner/Thermoformer machines. Facilities and Utilities Qualification including compressed air, chilled / potable / hot soft water, HVAC, and Vacuum / Dust Collection.

Las Piedras, PR

Responsible for computerized / PLC automated equipment validation (FETTE Tablet Compressing machine) and Building Monitoring Control System - IQ/OQ protocols development and summary reports generation.

Responsible for the development of Standard Operating Procedures (SOP's) for new High Speed Packaging Line equipment including: Operation, Change Control, Security, Backup and Restore, and Contingency & Disaster Recovery. Protocols (IQ/OQ/PQ) development and execution and summary reports generation on the process and packaging areas for pharmaceutical.

Duties included procedures (SOP's) development of Packaging machinery and issuance and execution of Installation / Qualification protocols for packaging equipment (Roller machine, Metal Detector, Case Packer and Bundler machines). Qualification Execution of computerized electronic inspection system on the Packaging Lines (RPLEVS). Participated in the.