LIDA M. RIVAS MARTINEZ

Colonial Woods, Orlando FL, 32826 Cellphone 407-***-****

Email: ad3n2i@r.postjobfree.com

CAREER

PROFILE

Professional with

strong

manufacturing

experience within

the

pharmaceutical

industry. Vast

knowledge of solid

dosage

manufacturing

operations

including

manufacturing

processes,

packaging,

inventory systems,

maintenance

engineering

systems, auditing,

process

improvements

(Lean), technology

transfer for new

products,

management, and

control of

manufacturing

documents,

change

management,

validations,

qualifications,

supervision, and

project

management.

Knowledge of the

Federal Code of

Regulations

(CGMP). Certified

Project

Management

Professional,

Computer literate

PC (Word, Excel,

Visio, Power

Point, MS Project,

Trackwise, etc.).

Bilingual (English

& Spanish).

PROFESSIONAL EXPERIENCE

Verista; Life Science Solutions Consultancy Firm - Sr Project Engineer Oct 2018 - Present

• Pfizer-Compliance Manage / EHS Safe Work Permit System

• Alcon - CSV Data Integrity

• Fagron – Technical Writer Deviations

• Mead Johnson - CSV

• Pfizer - GMP Documentation Contractor / Change Management Contractor

• Catalent – Manufacturing Technical Writer Deviation Neolpharma Pharmaceutical CMO - Project Manager Jul 2014 - Apr 2017

• In charge of new products introduction launch; Coordination of activities from experimental lots, validation lots, IQOQ’s, facilities modification, vendor certification, manufacturing schedule, clean/dirty hold time studies, micro, stability. Lab methods transfer. Also provide support in the NDA and ANDA submissions and FDA preapproval inspections.

• Lead of cross functional teams.

• In charge of clients’ accounts from the project /special studies quotations, change orders, bill payments and special request studies like holding time and excursion study. Maintain close communication with the client.

• Technical Writer Deviations Investigations, CAPA, risk management and generation of all kinds of required regulatory documentation for FDA and COFEPRIS. I.S.P.V. - Project Manager at Amgen (Biotechnology) Contractor Feb 2013 – Jul 2014

• Technology transfer of several new products within the company; accomplished in a timely matter.

• Products / Equipment’s decommissioning.

• Multiple projects were managed towards strategic business and other organizational objectives. Lead of cross functional teams.

• Liaison with project stakeholders to define and deliver their needs.

• Identify, effectively communicate, and resolve project issues and risks. Develop risk mitigation plans.

• Coach, mentor, and collaborator, influencing them to take positive action and accountability for assigned work.

Vantage Consulting Group; Process Advisor at Pfizer / Novartis - Oct 2011 - Feb 2013

• Creation and implementation of the required Packaging and Manufacturing GMP documents for the introduction of new product launch.

• Creation / revision of Manufacturing Batch Records, SOPs in compliance with GDP.

• Creation and execution of Packaging protocols qualifications.

• Support to CAPA investigations using Trackwise.

• Support to the Cleaning Validation activities in the packaging area. Amgen – Customer Services IS/IT Nov 2011 - Dec 2011

• Customer Services (Electronic Batch records).

• Customer services for IS internal clients.

• Creation of "Parameter Value List (Validation Parameters)" for the “Electronic Batch Electronics.”

• Creation/revision of required documents for the “Electronic Batch Records". LIDA M. RIVAS MARTINEZ

Colonial Woods, Orlando FL, 32826 Cellphone 407-***-**** Email: ad3n2i@r.postjobfree.com

Colegio Universitario del Turabo (SAGM) - Professor at nights Feb 2011 – Aug 2012

• Delivery of courses related to the pharmaceutical manufacturing such as: o Pharmaceutical Solid/ Semi Solid Dosage Manufacturing Process o CGMP’s

PR Pharmaceuticals / AstraZeneca Feb 1988 – Dec 2008

• Project Management Advisor – New product launches.

Coordination of the technology transfer activities and introduction of new products to the market.

Trainer of Project Management Techniques, Microsoft Project Software Training’s, and Introduction of Lean Concepts. Provide a Project Management Training in AstraZeneca Operations in Brazil

• Industrial and Planning Engineer

Establishment of an inventory control system for the Engineering Maintenance Stock Room spare parts including a successful Audited Cycle Counts system.

Managed the startup of the Canovanas facilities maintenance stock rooms and maintenance operations.

Managed the installation and connection of the communication switchboard between Carolina and Canovanas sites. Optic fiber.

Subject Matter expert in the implementation of SAP.

• Industrial Engineer

Successful Documents Implementations thru Change Requests for over thirty new presentations within the manufacturing and packaging area.

Change Control Management of the Manufacturing Operational documents. Creation, maintenance, and auditing of BOM's and Routings. Customer services of external and internal clients. SOP’s revision and custody of documents.

• Pharmaceutical Process Associate

Process validations and qualifications of several major equipment’s. Support to the Computer Validation Section in the creation of protocols and execution of protocol / Script Tests.

EDUCATION

1982 - 1987 Bachelor's degree in industrial engineering, Universidad Politéctica de Puerto Rico, Hato Rey, PR. Industrial Engineering Department. (Night student). 1978 - 1982 University of Puerto Rico, Mayaguez Campus, Mayaguez, PR., Industrial Engineering TRAININGS AND CERTIFICATIONS

• Project Management – Certified PMP since 2005

• Generation and Management of GMP documents

• GMP Auditing - GMP Institute

• Lean Manufacturing

• Microsoft Programs (Word, Excel, Power Point, Visio, Microsoft Project)

• Customer Services

• Quality Engineering Academia

• Quality by Design

• Technical Writing

• SAP Implementation (Maintenance Subject Manner

Expert)

• Trackwise

• Human Behaviors in Organizations

• Software Trainer (Train the Trainer)

• Design of Experiments

• MRP BOM's and Routing's

• Covey Seminar

• Management by Responsibility

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