Quality Assurance Control
Resume:
GUSTAVO VELAZQUEZ DAVILA
Patilas, PR 00723/Km 118/Carr#3
**********@*****.*** 787-***-****
JOB TARGET
Area where my knowledge and skill can be used to achieve company goals.
OVERVIEW
Experienced chemist highly skilled and conditioned to serve within highly
sophisticated and regulated pharmaceutical industries. Knowledgeable of
GLP, GMP, HPLC, UV/VIS, TLC, GC and other primary technology requirements
and work methods. Effective in the analysis of difficult issues,
performing under the challenges of multiple tasks and closing due dates.
Ability to work as part of a team, handling details and preparing accurate
and valuable documentation. Bilingual, Spanish and English.
EXPERIENCE
WYETH PHARMACEUTICAL Guayama, PR
LABWARE LIMS Master Data Specialist 2005 to Sept 2009
Experience in the Validation process in the LWLIMS project, working in the
implementing of difference phases of the LWLIMS project including Stability
process, Purified and Potable Water& Bulk solid dosages and Raw Materials.
The experience is based in the analysis configuration including critical
and no critical chemical testing, new folder creation in the system and
validating folders already created to assure the proper configuration and
work of it. Experiences include the management of the experienced
contractors organizing the workload and the distribution of duties related
to their contract. The experience include the complete configuration of the
Raw Material area, including analysis creation, test scripts creation and
executions objects creations, standard and reagents, formula creations
using Lims Basics, training sessions for new users including productions
workers and Laboratory Chemists.
WYETH PHARMACEUTICALS COMPANY Guayama, PR
QA Lab. Analyst (Raw Material) and Chemist Team Leader
1998 to 2004
Handle work distribution as Raw Material Team Leader with people under my
direct supervision and coordinate material release with the Manufacturing
Area Managers and Supervisors. Serve in strongly independent role
contributing to QA measures preparing test standards, samples and
solutions. Conduct equipment validations, preventive maintenance and
troubleshooting activities. Document and submit reports to area reviewer
and support other teams in the completion of products for release. Use
HPLC, GC, A.A, IR, UV/VIS, follow methods, view integrations and
process/analyze data. Participate in the validation of new products.
Services in the use of balances, pipettes, Karl Fischer,
HPLC, GC. Experience reviewing validation protocols during the validation
activities for QA Incoming equipments.
Conduct chemical and physical laboratory tests to support scientists in
qualitative and quantitative analysis, quality control, maintenance of
environmental standards, and other work involving experimental,
theoretical, or practical applications of chemistry and related sciences.
Analyzed conductivity and viscosity measurements, titration and other wet
chemistry tests.
WHITHE HALLS ROBINS PHARMACEUTICALS Guayama, PR
Quality Assurance Technician 1991 to 1998
Audit process for manufacturing, warehouse and packaging areas. Approve
packaging component to support packaging process.
Approve cleaning for equipment and rooms in production areas. Sample
purified water, Raw Material, Environmental sample as air
to make sure product was free of air contaminant. Participate in validation
activities in manufacturing area as Reverse Osmosis Water System,
compressing area coating area and others. Conduct chemical test to the
purified water, packaging component and to the solid dosage
product. Good knowledge in manufacturing and packaging process.
EDUCATION
Master Degree Network and Security- In Progress / Inter American University
Guayama, P.R
Servers 101-HP Learning Center
Small Business Networking- HP Learning Center
Cisco Certified Network Associate (CCNA) - Finished 2008
Computer Repairing Technician Caguas P.R 2006
UT&CUH UNIVERSITY OF PUERTO RICO Caguas/Humacao, PR
BS Chemistry 1997
Other courses: Unit Operation in Chemical Engineering, Probability and
statistic, Management, Money and Bank, Economy and Biochemistry, Calculus
I, II, III, Network Administration I&II, System Analysis and Design.
SEMINARS / CORPORATE TRAINING
. HPLC Maintenance and Troubleshooting, Chromatography Institute of
America, 2005
. Trackwise Quality Management System Basic Training, 2005
. Analyst Certification Program by Wyeth Pharmaceutical, 2005
. Phenomenex HPLC Column Maintenance
. Simpatec Particle Size Analyzer
. Wincats/ Camag TLC Analyzer
. LWLIMS Certified System Administrator V6.0
. SAP
. SQL LIMS
SKILLS
MS Office 2007 (Word, Excel, PowerPoint), Internet Search Engines, SQL
Lims, Perkin Elmer's Turbochrom Client Server, Water's Empower, and
Trackwise. Hewlett Packard, Perkin Elmer, Hitachi, Vankel, Distek and
other analytical instruments. QA 1996 symbol employee and perfect
attendance during four consecutive years. Basics of Ethernet Technologies,
TCI/IP, Network media, IP addressing, Routing. Basics of configuring
routers, Routing protocols, TCP/IP concepts, Access lists, Installation of
Microsoft Operating Systems as: Windows XP, Windows Vista&Windows-7.
Knowledge in computer hardware installation and troubleshooting
Reference: Furnish Upon Request
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