Process Manufacturing
Resume:
Javier E. Santiago Centeno
Cond. San Antonio I Apt. #404, Caguas, PR 00725
Telephone 787-***-**** Cel: 787-***-****
E-mail address: *******************@*******.***
PROFESSIONAL PROFILE
Over 25 years of experience in the pharmaceutical and chemical industries. Licensed chemist with
supervisory experience in the Quality and Manufacturing areas. Supervision of Professional, Technical
and Process Operation teams in different operating shifts. Dynamic and well organized with high
standards of personal and professional ethics. Bilingual: Spanish – English.
KEY ACCOMPLISHMENTS
• Improved Operator productivity by efficient allocation of resources resulting in overtime-cost
reduction, and schedule completion improvement from 75% to 93%.
• Performed revision of process documentation and conducted classroom training in process and
new products manufacturing for approximately 120 associates. Reduced batch documentation errors
by 50% over a three months period, improving GMP compliance and QA performance.
• Conducted vendor and replenishment analysis revision, resulting in cost savings of 35% while
assuring the procurement of quality raw materials, and supplies for laboratory and process
operations.
• Developed alternate Analytical Methodology for Assay and Contents Uniformity, achieving a
40% reduction in release time. Reduced cost and safety exposure in the process and provided quick
response to QA and operations to achieve inventory reductions and attainment capacity cycle time.
• Implementation of new technology in the manufacturing area and the use of electronic batch
record.
EXPERIENCE
Wyeth Pharmaceutical, Guayama, Puerto Rico 1998 to 2008
Production Supervisor: Responsible to supervise the manufacturing process such as granulation,
compression, coating and branding stages with a weekly average of production of 15 to 22 lots
equivalent to over 15 million units each. Supervised, trained and evaluated a team of 28 operators.
Generated and closed Manufacturing Investigation Reports (MIR’s) within 20 days. Performed MIR’s
interviews of witnesses to collect investigation information. Participated in multidisciplinary
rounds/groups to identify investigation root causes. Communicated with other specialist staffs to find
out best solution of given problem. Maintained and managed internal audit plans. Partner with other
departments within production facility to support wide range of on-going projects.
Zenith Goldline Pharmaceuticals, Cidra, Puerto Rico 1995 to 1997
Process Supervisor: Supervised a team of 20 operators in the raw material weighing process,
granulation, compressing, encapsulation, and coating in the Manufacturing Department with an average
weekly production of 18 to 24 lots with theoretical weight of 600 kilos. Generated, investigated and
closed IR’s (Investigation Reports). Performed internal audit.
Javier E. Santiago
Resume page 2
Warner-Lambert Inc., Vega Baja, Puerto Rico 1993 to 1994
Process Supervisor: Supervised a team of 12 associates (operators) in the granulation area in the Tablet
Business Unit with an average weekly schedule and production of 7 to 8 lots with theoretical weight of
1,118 kilos, equivalent to over 12 million units each. Responsible for the raw material weighing process
and capsule filling area of the Capsule Business Unit for approximately ten months.
MOVA Pharmaceutical Corp., Caguas, Puerto Rico 1991 to 1992
Laboratory Supervisor - Multiple Source QC Dept.: Responsible for the supervision of laboratory
operations for Raw Materials, Validations, and Finished Goods area in two shifts with up to 24
associates (Chemists and Lab Technicians). Also, in charge of the Stability Area for a period of six
months; Generated and closed Laboratory Investigation Reports (LIR’s) within 20 days. Performed
LIR’s interviews of witnesses to collect investigation information. Carried out Lab audits to check out
quality and stability of manufactured products.
EDUCATION
Catholic University of Puerto Rico
Bachelor Degree in Science, Major in Chemistry, Minor in Mathematics
SEMINARS
GMPs courses, training and seminars.
•
Statistical Process Control Methods.
•
Investigation and CAPA Workshops.
•
Theory and Principles in Manufacturing Process, Colegio de Farmacia, Rio Piedras, P.R.
•
SKILLS
Excellent communication and interpersonal skills
•
Fast learner, self-starter with very good follow up skills
•
Working knowledge of Trackwise and SAP systems
•
Quality Auditing
•
Root Cause Investigation
•
Problem Solving
•
Attention to details
•
Knowledge of cGMP’s
•
Professional Affliations
Licensed Chemist #2513, Colegio de Químicos de Puerto Rico
ASQ Member #63966265
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