Lida R. freelancer experto en Redacción Comercial, Traducción al Español

Lida R.

Make it right the first time.

Ingeniería y Manufactura

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Sobre mí
Soy ingeniero industrial con vasta experiencia en la industria farmacéutica como ingeniera, supervisora de empaque, planificación de ingeniería,  gerente de proyectos y otros. Tengo experiencia manejando documentos CGMP  para agencias reguladoras como  FDA y  COFEPRIS ademas de experiencia en validaciones de proceso y cualificaciones de equipos.
Domino los dos idiomas espanol e ingles al igual que manejo a perfecion los programas de Microsoft; Words, Excell, Acess, Visio y Project.
Puedo generar los procedimientos operaciones y le limpieza a igual que el  programa de mantenimiento preventivo  para cualquier equipo utilizando el manual del manufacturero.
Historia laboral
Neolpharma -  Project Manager                                July 2014  -  April 2017
Succesfully managed a new product introduction  including  NDA And ANDA  submissions. These  new product represents millions of dollars on profits to the plant.  This effort included proposals, budget, timeline and follow up if scheduled activities for the implementation of an effective product lunch.
Responsible and accountable for the coordinated management of multiple projects oriented toward business strategy and other organizational objectives.
Execution of investiongations,CAPA’s and generation of all kind of GMP Documents.

I.S.P.V. -  Project Manager  at Amgen (New products Tech Transfer) Contractor        Feb-2013 –  July 2014
Succesfully managed the technology transfer of several new product to the plant whithin schedule,  representing a significant profit to the company.
Multiple projects were coordinated  toward strategic business and other organizational objectives.
Processes were defined to  best suite each project complexity.
Liason with project stakeholders directly to define and deliver their needs.
Identify, effectively communicate, and resolve project issues and risks. Develop risk mitigation plans.
Coach, mentor, and a team player, influencing them to take positive action and accountability for assigned work.  

Vantage Consulting Group -  Pharmaceutical Consultant                      Oct-2011-  Feb-2013
Pfizer Consumer Guayama –  Project Manager/Sr. Consultant / Process Advisor           
(Perform services for Novartis,  & Pfizer Pharmaceuticals)
Creation/ monitor and  implementation of all the required Packaging and Manufacturing SOP’s for the introduction of new product launch.  Also creation of "Visual Aids" in the packaging for the identification of  the critical cleaning points of the packing lines.
Creation / revision of Manufacturing Batch Records associated to the new product launch.
Creation and executing  of Packaging  protocols for line trials.
Support to CAPA investigations using Trackwise.
Support to the Cleaning Validation activities in the packaging area.
Monitoring of the activities required to complete the qualifications of new packing lines.

Amgen Manufacturing Unlimited – Contractor                         8Nov11  -  15Dec11
IS / Customer Services (Electronic Batch records.)
Creation of over 50 new  "Parameter Value List (Validation Parameters)" for  the "Batch Electronics.
Creation/revision of  associated documents for the  "Electronic Batch Records".



Colegio Universitario del Turabo  - Teacher at nights;                Feb 2011 -  August 2012
Delivery of courses such as  Pharmaceutical Solid Dosage Manufacturing Process  and  GMP’s.

IPR Pharmaceutical Inc (Former ICI Pharmaceuticals)                     1988 – 2008
Part of AstraZeneca Inc.  Carolina – Canovanas PR

2003 – 2008    Project Management Advisor - Utilization of Project Management techniques to ensure timely completion of Pharmaceutical Projects.  Facilitation of multidisciplinary team meetings. Coordination of the technology transfer activities and new products introduction to market. Preparation, coordination and  trainer of Project Management Techniques ,  Microsoft Project Software Training's and  Introduction of Lean Concepts.
Achievements:    
Trainer of several course such as Project Management, Microsoft Project and AstraZeneca Project Management Framework.
Three new product introduction projects were successfully managed unpo the FDA Approval and subsecuent products launch within schedule.
1993 – 2003    Industrial and Planning Engineer – Maintenance and Control of Inventory Systems; Supervision of the Maintenance Stock Rooms in the Carolina and Canovanas facilities.  Management of the maintenance planning system. Preparation and management of the Engineering Planning Section Budget.
Achievements:    
Established a  inventory control system for the maintenance engineering stock rooms as well as a Cycle Counts system.
Managed the start up of the Canovanas facilities maintenance stock rooms and maintenance operations.
Managed the installation and connection of the  comunitacion switchboard between Carolina and Canovanas sites.
Subject Matter expert in the implementation of SAP.
Supported  the Computer Validation of the SAP Program. 
1990 – 1993    Industrial Engineer – Change Control Management of the Manufacturing Operational documents. Creaton maintenance and auditing of BOM's and Routings. Application of project management techniques for new products launch.
Achievements:
Effective Documents Implementations thru Change Requests for over 30 new presentations within the  manufacturing and packaging area.
Server as a project management trainer for the AstraZeneca Operations in Brazil. 
1988 – 1990    Pharmaceutical Process Associate - Process validations and qualifications of several major equipments.  Support to the Computer Validation Section in the creation of protocols and  performing Script Tests.
    Achievements
Timely and effective qualification of major equipments and support in  validations activities.

Zenith Laboratories Cidra, PR                                     1985 - 1988
1985 – 1987     Packaging Supervisor - Supervision of the packaging operations. 
1987 – 1988    Technical Services Specialist.  – Process validations and manufacturing support.
Achievements:
Creation of the validation protocols
Creation and custodian GMP Documents sucha as  Manufacturing SOP’s, Validation Reports.

Mc Neil Pharmaceuticals      Dorado, PR                             1984 - 1985
    Packaging Supervisor (third shift) - Supervision of the packaging operations.  Coordination of packaging line  pilot runs for the production lines. Supervision of the plant during the third shift. Identifying process control parameters for the granulation and compression areas. Documentation review and approval for production shipment.
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Posición del perfil: Bronze

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