ALMA G. BATISTA

RESUME

PO BOX 8076 Humacao, Puerto Rico 00792 Tel (787) 850-3482 Home, Tel (787) 852-0909 Work

QUALIFICATIONS

Over seventeen (17) years of experience in the pharmaceutical industry with four (4) years in the Environmental Regulatory Affairs and Industrial Hygiene fields and thirteen (13) years in solid dosage forms processing related areas. Have held positions as Technical Operations Specialist, Sr. Process Engineer, Production Leader, Process Engineer, Senior Project Engineer, Staff Engineer and Engineer. Broad knowledge in pharmaceutical production (mainly solid dosage forms: tablets and capsules), project development, equipment procurement, equipment installation, plant start-ups, process troubleshooting, and validation in conformance with cGMP’s and FDA requirements. Literate in personal computers (PC) with skills in Excel, Word for Windows, Lotus 123, Microsoft Project and Power Point besides others.

WORK EXPERIENCE

August 1999/Present ICN Pharmaceutical Inc., Humacao, Puerto Rico

Technical Operations Specialist

Responsible to provide technical support to the manufacturing operations by conducting product and technology transfers, process and cleaning validations, and qualifications including installation, operational and performance to equipment, facilities or utilities. Provide technical assistance to the operations in process optimization and troubleshooting to equipment and processes by using adequate problem solving techniques.

September 1983/ July 1999 SYNTEX /ROCHE, Humacao, Puerto Rico

Sr. Process Engineer Jan. 1996/July 1999

• Responsible to conduct product transfers and process validations coordinating all related activity including sampling, testing, packaging and stability studies.
• In charge of the operation and monitoring of the USP Purify Water System including pretreatment and distribution loops.
• Provide assistance to the production areas in process and equipment troubleshooting by using problem solving techniques.
• Develop process optimization projects directed to improve efficiency, increase productivity and lower operational cost, maintaining a high quality standard.

OC's/Special Compound Production Leader Oct. 1992/ Jan. 1996

Responsible for the administration of a production area from the stage of weighing, granulation, compression, encapsulation, coating and printing and start-up of a fully automated facility with integrated computerized equipments. The facility was designed to work in a complete containment environment and operators are required to be full gowned for safety reasons. Managed a crew of one exempt and 27 non-exempt employees and controlled a Budget of about $1.2M.

PROCESS ENGINEER June 1987/ Oct 1992

• Assigned to a Project Team, since April 1990, to work in a Plant Expansion Project evaluating plant conceptual process operation, equipment arrangements and process control system designs to meet project goals. The process control system must handle the electronic worksheet, processing equipment data collection, material request, production labor and others. Responsible to manage the project to design a Weighing Area within the Plant Expansion Project.
• Responsible to monitor the manufacturing operations to find areas of improvements in order to increase productivity, efficiency and lower operational costs, convert them to projects and implant them.

SENIOR PROJECT ENGINEER September 1983/ June 1987

Responsible to handle all aspects of environmental regulatory affairs and occupational health and safety programs. Manage a crew of two Wastewater Treatment Plant operators and a staff engineer. Lead projects heading to keep Company in compliance with the EQB and EPA regulations.

ENGINEER, E.I. DUPONT DE NEMOURS & Co., INC, Belle, West Virginia February 1982/ May 1983

As part of the Environmental, Power, and Services group, Biochem-Technical Division: I worked on the reduction of the Powerhouse stack emissions; handled liquid waste incineration in coal burning boilers and assisted in the implantation of safety inspection programs.

PROFESSIONAL CREDENTIALS

BS Chemical Engineering, Magna Cum Laude, 1981, University of Puerto Rico (Meager Campus).

Member of the National Engineering Honor Society, Tau Beta Pi, 1981.

Member of the CIAPR Professional Engineer License 10272

CAREER DEVELOPMENT

• Tablet Manufacturing Puerto Rico, Pharmaceutical Production TechSourceÒ , November 2000
• Pharmaceutical Technology for Liquids and Semisolids, TSI, August 2000
• Approved Professional Engineering (PE) Test (Chemical Engineering), on April 2000
• A software Validation Approach to :21CFR 11 Electronic Records; Electronic Signature, Guerra Consulting Group, Inc, January 2000
• Programmable Controls Allen Bradley SLC 500, Carlos Andreu
• Design of Experiments, Center for Applied Science and Engineering, June 1998
• Acceptance Sampling by Attribute, Center for Applied Science and Engineering, August 1998
• Applied Probability and Statistics, Center for Applied Science and Engineering, June/July 1998
• Pharmaceutical Technology Course, TSI, February 1998
• Batch Record Review and Investigations, PharmaNet, Inc, Mr. John Y. Lee May 1997
• Principles of Validation for FDA-Regulated Industries: An Introductory Workshop, April 1997
• Interaction Management: Tactics for Effective Leadership, 1997
• Transformación Cultural en el Proceso de Reingeniería, DynExcel, Inc., 1995
• Beyond Reengineering, Dr. Michael Hammer, 1995
• Reengineering-The Implementation Perspective, Dr. Michael Hammer, 1994
• Technical Writing Skills Course, María Cervoni, July 1994
• FixDmacs Technical Training, April 1992
• Glatt Air Techniques Doorstep Seminar, Glatt Air Techniques, Inc.-1990
• Data Communication: Fundamentals and Beyond, The American Institute, Inc.-1988
• Automation of Batch Processes, The Center for Professional Advancement-1988
• Water Purification Seminar, The College of Engineers and Architects of PR, 1987
• Tablet Manufacturing, Society of Manufacturing Engineers-1987
• Fluid Bed Granulating, Drying, and Particle Coating Review, Glatt Air Techniques, Inc.-1987
• Glatt Maintenance Training, Glatt Air Techniques, Inc.-1987
• Dynamics of Supervision, Success Motivation Institute, Inc.-1986
• Seminario sobre el proceso gerencial, Instituto para la productividad- 1984

Personal References will be submitted upon request.

Keep this Resume strictly Confidential.

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