Manufacturing Process

Luz Milagros Lorenzo Pizarro, BSCH, MBA

** ******, #*-**** ******* de Rio Grande, Rio Grande, Puerto Rico 00745

787-***-**** *************************@*****.***

Summary of Qualification

Professional with eight years of experience in Manufacturing and Quality in

the Pharmaceutical and Education industries. Strong experience in

parenterals product manufacturing. Ability to perform multiple tasks and

manage daily activities under high-pressure environment and minimum

supervision. Proactive and a consummate team builder. Passionate about

improving process and people behaviors. Responsible, organized and self-

starter with proven leadership skills. Excellent interpersonal and oral

written communication skills. Strong analytical skills, quality oriented

and fast learned. Self-confidence and motivated to make a difference.

Computer literate with extensive knowledge in Microsoft Office (Word,

Excel, Power Point, and Publisher), Outlook, SAP, GxPharma, Kronos, OEE,

Group Wise, TIMS, Iso Train, Track Wise, CAPA, Production Batch Record

System, Nova manage, MES. Fully bilingual in Spanish and English.

Professional Experience

Universidad Metropolitana, Bayam n, Puerto Rico

2010 - 2010

Faculty Member - Programa AHORA

. Teached graduate students in Introduction of Entrepreneurial Business

Development to complete a Bachelor Degree.

Achievements

. Influenced 40% student's decision to continue graduate studies.

. Achieved that 100% students of course develop their own business plan

with satisfactory grade results.

Wyeth (Pfizer), Carolina, Puerto Rico

2006 - 2010

Manufacturing Supervisor

. Monitored process activities through actual presence on the

manufacturing floor.

. Assured optimal workflow of the area with assigned resources and

equipment complying with schedule attainment goals.

. Assured that direct and indirect reports were properly train to

execute assigned tasks following cGMP's, SOP's, company policies and

environmental, public health and labor laws.

. Prepared and reviewed batch records documentation and close

manufacturing process orders.

. Generated SOP's, Job Aids or other job related instructional aids, and

lead investigations of process deviations in accountability area.

. Teamed with QA/QC, Technical Services, and Engineering and Maintenance

to assure timely and successful execution of validation, construction,

and maintenance projects.

Achievements

. Completed one hundred percent of Master Batch Record Simplification

Project to improve the manufacturing documentation process.

. As a result of reviewing standardizing procedures and reorganizing

shift schedules, improved sealed product output equipment from a

range of 30% - 40% to a new range of

55% - 65%.

. Participated in over 20 Media Fill (Aseptic Process Simulations)

during 2006 to 20010 achieving cero product contamination.

. Exceeded manufacturing production goals.

. Achieved cross training of 90% of employees.

. Accomplished 100% fully trained employee and attendance.

. Reduced over time below the target of 3% during 2006 to 2010.

Luz Milagros Lorenzo Pizarro

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Wyeth, Carolina, Puerto Rico

Documentation Specialist II - Change Control

2006 - 2006

. Managed and coordinated the Change Control meetings and performed

evaluation of changes.

. Evaluated Change Control to assure that complies with all supported

documentation requested.

. Closed and implemented the changes through the Change Control Program.

. Informed to impacted areas on the site the closure date of the change

controls.

Achievements

. Reduced the cycle time change control initiation and closing process

through direct support to Production Units and providing change

control status and follow-up.

Documentation Specialist II - Master Batch Record

2002 - 2006

. Performed and coordinated Master Batch Record's revisions to assure

that Production Batch Records reflects current protocol requirements,

manufacturing activities and Good Manufacturing Practices regulations.

. Provided support in the MBR Area for validation projects, regulatory

submissions, product reformulations, and new processes parameters.

. Originated and reviewed Standard Operating Procedures.

. Approved Master Batch Record of manufacturing commercial batches.

. Wrote the Annual Product Review Report of the Compliance Department

/Master Batch Record Area, for manufactured products.

. Provided support to Manufacturing and Packaging Areas issuing

Production Batch Records using Novamanage and SAP Programs.

Achievements

. Improved the documentation process of the manufacturing process

including controlled forms to the MBR's.

. Received recognitions of Zosyn and Parenterals PPU related to the

collaboration, support, and contributions in the revision and

preparation of MBR's on time for the start-up of the plant after a

shutdown.

. Completed on time MBR revisions for the following projects: Tygacil

Validation and Regulatory Submissions Batches, Zosyn Reformulation,

SAP implementation, Cozzoli Filling Line Replacement, Dryer Paco,

Quique and Robert validations, and addition to Tank 2300.

. Coordinated and performed revisions for different validation and

improvements projects.

Alpha Research Labortories & Consulting, Humacao, Puerto Rico

2002 - 2002

Development and Validation Laboratory Chemist

Quality Control Analyst

. Provided support in the protocols revisions and development.

. Documented laboratory tasks reports.

. Performed analysis for in process or finished products of gel caps,

gel tabs and caplets per process as Assay, Description, Content

uniformity, and Dissolution using HPLC's Systems.

Achievements

. Accomplished 100% training during one-month period.

. Promoted to Development and Validation Laboratory Chemist.

Luz Milagros Lorenzo Pizarro

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Education

Interamerican University of Puerto Rico, San Juan, Puerto Rico

PhD Regional and Interregional Business (GPA 3.50)

Approved credits: 21 credits

University of Phoenix, Guaynabo, Puerto Rico

MBA Management Business Administration (GPA 3.69)

University of Puerto Rico, Rio Piedras, Puerto Rico

BS Natural Sciences

Quality Medical Reps of Puerto Rico, Rio Piedras, Puerto Rico

The Professional Medical Representative Sales Course

Chemical Vapor Deposition for Nanocrystalline Particles

Trainings

. Train the trainer

. Good Manufacturing Practices

. Continuous Quality Improvements

. What you need to do during oral presentations?

. Organizational Behavior

. Organizational Development

Memberships

. Golden Key International Honor Society Membership

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