Plant Manufacturing

Profile: Over eight years of professional experience in the

pharmaceutical industry, with proven experience in regulatory,

compliance, quality, and validation areas. Strong management

skills with effective all levels communication and company

oriented. Hands on experience related to FDA applications,

Product Transfer, Annual Report, Annual Product Review, Change

Control, CAPA, Deviations, Risk Assessment, SOP, MBR, Stability

Program, Laboratory Tasks, Validation Protocols and Reports.

Team work oriented, good leadership, well organized, self-

starter, rapid learner, strong work ethic, computer literate,

good analytical and problem solving skills. Work under minimum

supervision and capable to handle multiple tasks and priorities.

Fully bilingual communication skills.

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Education: Master in Manufacturing Competitiveness

Polytechnic University of Puerto Rico, Hato Rey Campus

Graduate School of Industrial Engineering

377 Ponce de Le n Ave., Hato Rey Puerto Rico, 00918

Pharmaceutical Products Manufacturing, GPA 3.25

Project: Preparation of New Drug Application (NDA) / Abbreviated

New Drug Application (ANDA) Major and Moderate Post-approval

Changes for Parenteral Drug Products Site Transfer

Project Advisor: Jos A. Morales, Ph.D.

Bachelor Degree in Science

Inter American University of Puerto Rico, Bayam n Campus

500 Dr. John Will Harris Rd., Bayam n, Puerto Rico, 00957

General Microbiology, Cum Laude

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Experience: Regulatory Affairs acting Manager

APP Pharmaceuticals, LLC., Barceloneta, Puerto Rico

(September 2006 - Present)

Responsibilities within the position included but were not

limited to the following:

. Plant Regulatory Department head, reporting directly to

Corporate Regulatory Vice President and serves as the

primary liaison between Plant Regulatory Operations and

Corporate Regulatory.

. Establish and develop the Plant Regulatory Affairs

Department from start up to full operations of a liquid and

lyophilized parenterals plant.

. Participate as part of the Plant Management Compliance

Review Board for the evaluation of Deviations, CAPA's,

Investigations, Risk Assessment among others.

. Active participant during Regulatory Agencies Inspections

and communicate with FDA for specific product inquiries.

. Evaluate and approve all plant Standard Operational

Procedures and Master Batch Records during their revisions

by Regulatory Affairs standpoint.

. Work together with Corporate Regulatory and Product

Development in the preparation of FDA/CDER NDA's 505(b)(2),

ANDA's 505(j) and FDA/CDRH 510(k) for medical device.

. Prepare all of the product transfers regulatory

documentation to fulfill FDA supplements (PAS, CBE-30 and

CBE), deficiencies, and amendments.

. Build an effective Annual Report program in order to report

all regulatory annual changes for transferred and approved

products.

. Prepare annual budget against departmental necessities and

plant scope.

. Prepare Regulatory Department employees evaluation (Mid-Year

and Annual).

Validation Consultant

PHDS Corporation, San Germ n, Puerto Rico

(September 2005 - September 2006)

Responsibilities within the position included but were not

limited to the following:

. Generate, coordinate, and monitor execution of protocols for

manufacturing process validation, re-validation, process

improvement and troubleshooting, in parenteral and solid

dosage manufacturing areas.

Experience:

. Perform equipment (Parenteral Manufacturing, Solid Dosage

Manufacturing and Laboratory) commissioning, functional

requirements, user requirements, installation

qualifications, operational qualifications and performance

qualifications (FRS, URS, IQ, OQ and PQ).

. Development and Validation of new equipment/processes,

primary packaging components etc, among others as required

by the Business.

. Coordinate and conduct re-qualification of aseptic processes

with Media Fills.

. Revision and implementation of Manufacturing and

Laboratories Standard Operational Procedures (SOP's) and

Process Changes.

. Develop a Site Validation of New Cleaning Agents in

Parenteral Manufacturing, Solid Dosage Manufacturing and

Support Laboratories.

. Generate and review Quality Events and Corrective Actions

Preventive Actions (CAPA).

. Support in Corporate and Regulatory audits.

. Active participant of Technology activities (e.g.:

Validation Approach Time Reduction).

Compliance Stability Specialist

Wyeth Pharmaceuticals, Carolina, Puerto Rico

(2004 - September 2005)

Responsibilities within the position included but were not

limited to the following:

. Main liaison between local, corporate and international

Wyeth affiliates for New Product Transfer activities, issues

and FDA submission.

. Evaluate Stability Out of Specifications (OOS) results and

conduct Product Field Alert if is required.

. Recommend batches for Stability program as part of the

annual monitoring, validation batches, submission batches,

change controls and manufacturing deviations. Write and

review Stability studies.

. Generate Annual Stability Reports and Annual Product

Reviews.

. Collaborate with Complaint area in order to investigate

Customer claims.

Microbiology Analyst and Coordinator,

Wyeth Pharmaceuticals, Carolina, Puerto Rico

(May

2002 - 2004)

Responsibilities within the position included but were not

limited to the following:

. In charge of the plant water system monitoring (Water for

Injection, Clean Steam Condensate, Reverse Osmosis Water,

Process Water, City Water and Distilled Water) and

supervise technical operators in charge of water sampling.

. Support to Corporate and Regulatory audits.

. Lead person in charge of the implementation of Rapid

Microbiological Methods.

. Execute classical microbiological studies (LAL, Pyroburden,

Microbial Count, Coliforms, Bioburden, Sterility Test,

Microbial Limit, Growth Promoting Test and Biological

Indicators) for water, finish product, validation product,

bulk product, raw material and components.

. Develop method Validation for Sterility Testing

(Bacteriostasis Fungistasis) and LAL of new product.

. Perform environmental tests such as viable and non-viable

air monitoring and surface monitoring.

. Train and qualify new Analyst to perform Laboratory

testing.

. Review SOP's, Monographs and Change Controls.

. Prepare accurate and robust Laboratory Investigation

Reports (LIR's).

Undergraduate Investigator,

Alliance for Minority Participation, Bayam n, Puerto Rico

(2001 -

2002)

. Design and conduct experiments to generate novel

information regarding aquatic molds.

. Validation of BIOLOG microorganisms' identification system

for aquatic molds.

. Culture purification of developed microorganisms.

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Honors and Awards: Cum Laude in Bachelor Degree

Dean's List, Interamerican University of Puerto Rico at

Bayam n, 2001-2002

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Affiliations: Puerto Rico Society of Microbiologists (PRSM)

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Other Job Related

Knowledge and Skills:

Academy for Managers and Supervisors Certification (30

credits).

Pharmaceutical Validation, 21 CFR Part 11, RMM's, cGMP, ISO,

Aseptic Techniques, Total Quality Management,

Organizational Behavior, Root Cause Analysis, Train the

Trainer and Preparation of FDA Submissions and

Communicating with the FDA workshops.

Institute for Validation Technology and PRSM seminars.

Computer skills of software included but not limited to the

following: MS Windows, MS Office, Mini Tab, Stat Graphics,

SAP MRP II, COSMOS, TrackWise, SQL LIMS, BRIO, SIMS, ISO

Train, QLASS, Nova Manage, Global Product Status, LMS,

Documentum, CITRIX, and ISI Writer.

Excellent communication skills (verbal and written) in

English and Spanish, excellent interpersonal skills,

motivated and with initiative, self started, strong work

ethic, strong analytical and problem-solving skills,

oriented on teamwork and excellent leadership skills.

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References: Available upon request

Contact this candidate