Validation Consultant
Resume:
Bernard Damoudt
*******@*****.*** / *******@*****.***
Professional Profile
Validation Professional with over 14 years of experience within the
Pharmaceutical, Healthcare and Medical Devices Industry. Experience in
cleaning and process validations; and equipment, facility, and utility
qualifications under the FDA regulations. Excellent analytical and problem
solving capabilities. Work under minimum supervision and can handle
multiple tasks or projects. Capacity to copes the changes and negotiate
the schedule. Knowledge of Windows XP, Microsoft Office, Internet
Explorer, ISOTrain, Trackwise.
Key Accomplishment
. Qualify eight (8) Metal Detector for the Alesse and Lo/Ovral Products
to comply with a FDA regulatory commitment. This qualification
assured that the products aforementioned were in the parameter
established according to the FDA requirements.
. Evaluate containment equipment to reduce the exposition of the active
ingredient to manufacturing operator. This effort improved the safety
practices.
. Support the re-validation of Loette Product. This re-validation
improved the quality of the Product.
. Collaborate in the Validation of Lybrel new product. This validation
assured the launching of the product to the market.
. Execute the Performance Qualification for the Cycle Packaging Line
after installing the new Laser and Vision System. This qualification
assured that the cycle pack had all the tablets and that the cycle
pack was impressed the lot number and the date.
. Establish Cleaning Validation strategy for Lo/Ovral Product to
complete the validation in two (2) months. As a result this strategy
saved time due that the established time was six (6) to nine (9)
months.
. Execute the Performance Qualification of the Bottle Packaging Line to
launch a new product.
. Develop and Execute the Qualification of the Potable Water System.
Experience
Vantage Consulting Group
Present
Consultant - Responsible in developing the cleaning validation remediation
plan. Develop the protocol based on the remediation plan. Execute
Protocol. Generate final report. - Pfizer, Guayama.
IMPRA Engineering, PSC
2013
Consultant - Responsible in supporting the Cleaning Validation Project at
Mcneil, Las Piedras.
business Excellent Consulting
2013
Consultant - Accountable for the evaluation of the data and investigation
of the process validation to develop the final report at Mylan Caguas.
Weil Group, Caguas P.R.
2011 - 2013
Consultant - Responsible for the cleaning validation and qualification of
the equipment of packaging line, packaging validation, facilities and
utilities at Pfizer Guayama.
global Validation Solution
2010 - 2011
Consultant - Accountable for the qualification of the Annealing Vacuum Oven
at Medtronic Villalba.
Weil Group, Caguas P.R.
2010
Consultant - Accountable for the decommissioning of the equipment in the
Effexor Building at Pfizer Guayama.
US Census Bereau, Caguas, P.R.
2010
Crew Leader - Responsible for the supervision of the enumerators and Crew
Leader Assistants. Assign the work to the employee. Verify the completed
work of the employee. Document the performance and conduct problem.
Certify the payment registry. .
Wyeth Pharmaceuticals, Guayama P.R.
1999-2008
Technology Specialist III - Responsible for the development of Cleaning
Validation Protocol and Report. Identify and establish the equipment train
based on the worst scenario for Cleaning Validation. Measure and Calculate
the Product Contact Surface Area of the equipment train as part of Cleaning
Validation. Establish the sampling point of the equipment identified in
the train based on the criteria of hard to clean area. Calculate and
establish the surface concentration limit to be used as acceptance criteria
during the Cleaning Validation. Take swab samples for active ingredient
and cleaning agent residue, and presence of microbial growth for equipment
in the manufacturing and packaging area. Interpret the results obtained as
part of Cleaning Validation. Develop checklist or procedure to clean
manufacturing and packaging equipment. Develop and execute Installation,
Operational and Performance Qualification Protocol, and generate its
corresponding report for the following equipment Tablet Press Machine,
Metal Detector, Bottle Filler, Digital Transducer, Digital Transmitter,
Multitester or Checkmaster, Scales, and Cycle Pack Machine. Qualify the
system that controls the Air Handling Unit (AIR) and pressure in the
product room. Revise and develop procedures to operate equipment. Develop
cleaning sequence in "BATCH" for an automated Wash In Place (WIP).
Supervise contractor personnel during qualifications. Generate and
complete investigation as part of the failed qualification or validation.
Provide technical input to manufacturing investigation and support as part
of troubleshooting. FAT execution for containment equipment. Take of
samples, and interpret and verify data as part of the Product Process
Validation. Generate Product Process Validation Report. Generate Change
Control for Validation Projects.
Education
2005-2007 Turabo University, Caguas, Puerto Rico
Master of Business Administration
1992-1999 Polytechnic University of Puerto Rico, Hato
Rey, Puerto Rico
Bachelor Science in Electrical Engineering
Seminars
Integration and Validation of the Packaging Line, ARTEK
MIR Writing Investigations and Root Cause Training and Assessment, Wyeth
IPR Press Automation Controller (PAC2), IPR Company
Cleaning Validation, Steris
Solving Problem during the Compression, Wyeth
Computer system Validation Training, Technip BioPharm
Basic Statistical Training, Business Excellente Consulting
Introduction to Tablet Formulation, Emerson Science Center
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