ANGEL L. RIVERA ROMEU
e-mail: angelrivera.romeo@gmail.com
PROFFESIONAL BACKGROUND
Results oriented professional with over 20 years of comprehensive experience in the Pharmaceutical
Industry in areas such as Quality Systems (Quality Assurance, Quality Control, Technical Services,
Validations and Manufacturing). Able to identify organization areas of strength and weakness and
implement company quality standards and policies. Demonstrated ability to motivate staff to maximize
productivity and control project costs through the most effective use of work force and available resources.
SUMMARY OF ACCOMPLISHMENTS
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Over twenty years of healthcare manufacturing environment: Strong experience in Quality systems of
the regulated pharmaceutical, biotechnology, chemical and medical devices industry improving aspects
of quality for cGMP and FDA regulatory compliance requirements.
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Currently employed at Alpharma Integrated Solutions, Inc: Main local provider consulting technical,
compliance and regulatory services for the local pharmaceutical and biotechnological industry.
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Managed and developed numerous technical services projects: Experience managing exempt
employees such as Scientists, Manufacturing Operators, Quality Engineers, and Managers with high
level education credentials.
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Demonstrated working knowledge of MS Project, LIMS, cGMP, Documentum, EDMS, Trackwise, SAP
and MAXIMO.
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Help in the Implementation of 5S audits for Quality Control Labs (Chemistry, Microbiology, & Raw
Materials).
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CQE Academia, knowledge in Lean Manufacturing, 5S & Kanban Supply Chain principles, and Kaizen
projects.
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Investigator for investigations that were identified and corrected sources related to manufacturing, QC
laboratories and engineering supporting system failures.
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Experience train people in Cleaning and Process Validation Trends for companies located in Puerto
Rico territory.
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Experience in Pharmaceuticals Operations Consent Decrees and Remediation Activities: WarnerLambert Co. -1992, Schering-Plough Co. - 2002, Glaxo-Smithkline - 2006, Wyeth Pharmaceuticals 2008 and McNeil Healthcare LLC - 2012), Start-Up of Biotechnology Contract Manufacturing Operation
(CMO).
HOME (787) 251-8807 MOBILE. (787) 644-9425
AZUCENA STREET 100
ESTANCIAS DE LA FUENTE
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Page 1 of 7
ANGEL L. RIVERA ROMEU
e-mail: angelrivera.romeo@gmail.com
EXPERIENCE
Alpharma Integrated Solution, Vega Baja, P.R.
Sr Scientist Consultant: January 2012- Present
McNeal Healthcare LLC, Las Piedras P.R. (Consent Degree)
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Develop of Cleaning Validation Assessment to Manufacturing and Packaging Operations
Develop of Cleaning Validation Protocol and Summary reports
Execute of cleaning trials and verifications
Close cleaning validation packages as a part of remediation plan
Update cleaning procedures and Sampling Manual Site
Develop 2011 and 2012 Annual Site Cleaning Report
Help in the development of new Cleaning Equipment Guidelines as part of Concert Degree
Validation Workplan
Cook Pharmica,: A subsidiary of Cook Medical Company
Sr. Technical Services Scientist June 2009-December 2011
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Developed and executed analytical cleaning method validation protocol to determine residues in
upstream and downstream of biotechnology operations using TOC and ELISA techniques.
Developed laboratory administrative and compliance Standard Operation Procedures (SOP’s)
aligned to regulatory standards and requirements.
Performed analytical methods validation summary reports.
Performed accelerated and long term APIs stability studies summary reports.
Evaluated and recommended improvements to QC Laboratory SOPs.
Developed analytical methods such as SEC-HPLC, RP-HPLC, SDS-Page, IEF, ELISA and
Southern Blood analyses.
Performed Laboratory Investigation Reports (LIR) and CAPA’s for QC Laboratory and
Manufacturing departments.
Performed Risk Assessment during the Performance Qualification of the Isolator and Filling
Machine to determine the optimum sampling size and sampling location.
QCR Group, Caguas, P.R.
Sr. Process Validation Engineering: April 2006 – November 2008
Wyeth Pharmaceutical- Guayama, P.R. (Remediation Plan) (April 2006 to November 2008)
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Responsible for the oversight of contracted validation related activities including:
o Managed personnel according validation and manufacturing activities schedule.
o Prepared projects proposal with the objective to participate in bidding process.
o Developed Cleaning Validation Master Plan in Manufacturing and Packaging areas for Solid
Dosage Operations.
HOME (787) 251-8807 MOBILE. (787) 644-9425
AZUCENA STREET 100
ESTANCIAS DE LA FUENTE
TOA ALTA, PUERTO RICO 00953
Page 2 of 7
ANGEL L. RIVERA ROMEU
e-mail: angelrivera.romeo@gmail.com
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Developed Cleaning Validation Strategy for Packaging Operations using Risk Analysis to
determine worse-cases scenarios.
Developed Acceptance Criteria for Microbial Bioburden, Detergent and Active Pharmaceutical
Ingredients.
Developed Cleaning Validation Protocol, Final Reports, and Procedures for Manufacturing and
Packaging Operations.
Evaluated Cleaning Validation Package according company policies.
Coordinated validation activities with all supports departments.
Developed Process Validation Protocols for Blending, Wet Granulation, Milling, Drying,
Compressing and Coating Stages in Solids Dosage Presentation.
Data Analysis of Solid Dosage Processes Validation.
Legacy Pharmaceutical –Humacao, PR (June to August 2008)
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Lead Investigator for Laboratory and Manufacturing Investigation Reports (MIR) related to Solid
Dosage Processes.
Developed Process Validation Protocol for Blending, Wet Granulation, Milling, Drying and Coating
Stages in Solids Dosage Presentation.
PharmaServ. a PLAZA Consulting Group Division, Dorado, P.R.
Process Validation and Compliance Project Leader: April 2002 – April 2006
Glaxo-Smithkline Pharmaceutical –Cidra, PR (Consent Decree) (Nov. 2005 to April 2006)
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Supported Quality Systems and lead laboratory qualification activities required as part of remediation
activities for the Consent Decree:
o Qualification of Laboratory Instruments such as: High Performance Liquid Chromatography
(HPLC), Gas Chromatography (GC), Automated Laboratory Washer and Dissolutions Systems
to determine drug bioavailability and others.
o Lead Investigator for Laboratory Investigations and CAPA’s.
Abbott Biotechnology Laboratories –Arecibo, PR (April to November 2005)
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Responsible for the oversight of contracted validation related activities including:
o Supervised professional personnel.
o Participated in the development of the Site Start-Up Cleaning Validation Program.
o Developed Cleaning Validation Master Plan for Biotechnology Operation according the client
policies and Quality Standards.
HOME (787) 251-8807 MOBILE. (787) 644-9425
AZUCENA STREET 100
ESTANCIAS DE LA FUENTE
TOA ALTA, PUERTO RICO 00953
Page 3 of 7
ANGEL L. RIVERA ROMEU
e-mail: angelrivera.romeo@gmail.com
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Developed Product Contact and Equipment Surface Area document for Cell Culture,
Fermentation, Buffer Preparation, and Purification areas to support Cleaning Validation
Program.
Developed Cleaning Acceptance Criteria for Manufacturing Equipment train according new FDA
Guidelines for Cleaning Validation and Client Validation Standard.
Developed Cleaning Validation Protocols, Final Reports and Cleaning Procedures.
Knowledge in Delta V Interface program to control the operation of the Cleaning In Place (CIP)
Skid and cleaning parameters.
Abbott Pharmaceutical –Jayuya, PR (November 2004 to March 2005)
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I,O,PQ of Inspection Vision System of Klockner CP-10 Packaging Machine for solid dosage product
presentation.
Developed Process Validation Protocol for Dry Granulation, Milling, Drying and Coating Stages in
Solids Dosage Presentation.
Qualification of Laboratory Instruments such as: High Performance Liquid Chromatography (HPLC),
Gas Chromatography (GC), Total Organic Carbon (TOC), Particle Size Distribution Analyzer,
Dissolutions Systems and others.
Schering-Plough Pharmaceutical –Manatí, PR (Consent Decree) (April 2002 to April 2005)
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Supported Quality Systems activities required as part of remediation activities for the Consent Decree:
o Supervised a group of 9 professionals.
o Evaluated personnel performance and established new goals according to individual needs and
professional expectations.
o Managed projects budget according to company finances policies.
o Assessment of Stability Protocols, Sampling Plans, LIMS Specification, Analytical methodology
and Drug Product Specification with the goal of updating the Plant’s Stability Program according
to the submitted New Drug Application (NDA), Drug Master File (DMF), Food and Drug
Administration (FDA) Guidance for Drug Product Industry and Client Quality Standards.
 Responsible for identifying gaps and addressing them through appropriate Quality
System, i.e. change control, deviation, establishment of appropriate CAPA’s.
 Supported the following areas in their completion of significant steps as part of the
Consent Decree requirements: QA: Product Disposition, Documentation, Investigations,
CAPA’s; QC: Laboratory Standards alignment, test records, documentation
standardization, chain of custody controls.
 Remediation activities included gap assessments, identification of activities to addressed
identified gaps, perform required activities and provide data to close significant steps.
HOME (787) 251-8807 MOBILE. (787) 644-9425
AZUCENA STREET 100
ESTANCIAS DE LA FUENTE
TOA ALTA, PUERTO RICO 00953
Page 4 of 7
ANGEL L. RIVERA ROMEU
e-mail: angelrivera.romeo@gmail.com
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Helped to develop Cleaning Validation Master Plan for Pharmaceutical Plants according the
client policies and Quality Standards and aligned to the Consent Decree Remediation Work
Plan.
 Developed Product Contact and Equipment Surface Area for Manufacturing, Packaging
and Filling equipment trains for Cleaning Validation Program in Chemical, Parenterals,
and Semisolid Operations.
 Evaluated and developed Cleanability Studies, Process Assessment and Process
Definition with the objective to select an appropriate Cleaning Agent, improve cleaning
procedures and improve cleaning validation activities.
 Developed Cleaning Validation Seminar for Pharmaceutical Process Applications and
trained different pharmaceutical clients personnel.
 Audited Process, Cleaning Validation, Utilities, Support System, and Laboratory
Equipment Qualification validation packages according company policies and updated
requirements.
 Developed Cleaning Acceptance Criteria for Manufacturing; Filling and Packaging
Equipment train according new FDA Guidelines for Cleaning Validation in Chemical,
Parenteral, and Semisolid Operations.
Alpha Research & Consulting. Humacao, P.R.
Project Leader: SEPTEMBER 2000 – APRIL 2002
Schering-Plough Pharmaceutical –Manatí, PR (October 2001 to April 2002)
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Supervised 10 professional and clerical personnel.
Developed assessment, revisions and changes for quality systems procedures & regulatory
documentations as NDA, NADA, DMF and Veterinary Manufacturing Formulary (VMF) for Domestic
and International products according to regulations.
Pharmacia –Arecibo, PR (July to September 2001)
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Developed Laboratory Cleaning Recovery Studies and Method Validation Protocol, establishing the
Acceptance Criteria according the updated FDA’s guidelines and Company Policies.
Developed Cleaning Validation Protocols and Final Reports for API, and Solid Dosage presentations.
Wyeth –Lederle Pharmaceutical –Carolina, PR (March to June 2001)
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Analyzed Raw Materials and Packaging components according to the USP/NF and EP Pharmacopeias
compendium.
Supported Laboratory activity with Operation Cleaning Validation Samples.
HOME (787) 251-8807 MOBILE. (787) 644-9425
AZUCENA STREET 100
ESTANCIAS DE LA FUENTE
TOA ALTA, PUERTO RICO 00953
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ANGEL L. RIVERA ROMEU
e-mail: angelrivera.romeo@gmail.com
Dupont-Merck Pharmaceutical – Manatí, PR (September 2000 to February 2001)
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Developed Cleaning Validation Protocols, Execution and Final Reports for Parenteral Operation
(Formulation and Filling Processes) for ENDO Company.
Developed Cleaning Validation Protocols, Execution and Final Reports for Solid Dosage (Blend,
Granulation, Compression and Coating) Operations for SERONO Company.
Supported Media Fill Validation and Qualification of Stopper Machine and Incubators.
Janssen – Ortho LLC a Johnson and Johnson Co. Gurabo, P.R.
Laboratory Analyst: March 1996 – September 2000
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Analyzed Raw Materials according to the USP/NF and EP Pharmacopeias.
Reviewed raw materials tests, and packaging components according laboratory SOP’s and company
specifications.
Developed new standards operations procedures (SOP’s) to assure the control process in Quality
Operations according to the updated cGMP standards and company policies.
Parke-Davis Pharmaceutical Limited a Warner Lambert Co. Vega Baja, P.R. (Consent Decree)
Laboratory Analyst: August 1992 – March 1996
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Analyzed raw materials, finished products and stability studies according the United States
Pharmacopeia and National Formulary (USP/NF) references.
Participated in develop and implementation of Laboratory Analysts Certification Program, cGMP’s, Job
Function and Safety as a part of the company Education Development Programs.
Experienced writing laboratory investigations and deviation reports.
Developed equipment qualification protocols and performed Installation Qualification (IQ), Operational
Qualification (OQ) and Performance Qualification (PQ).
Experienced in analytical methods transfer and validations activities.
PROFESSIONAL COURSES_____________________________________________________________
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Manufacturing / Quality Systems:
Quality Engineering Academia, Kepner-Tregoe Problem Solving and Decision Making Course, 21CRF
and GMPs courses for Pharmaceutical, Chemical, Biotechnology and Medical Devices Operations,
Train the Trainer Workshops, Part 11 21CFR for Electronic Records & Electronic Signatures, CAPA
and Root-Cause Analysis Workshop, PathWise Training for Investigation, Trackwise Course and
Applications, Statistical and Risk Management for Pharmaceuticals Processes, SPC Course, Quality
Planning and Control Courses, Cleaning Validation and Process Validation Seminar, Quality by Design
Course, and others related courses.
HOME (787) 251-8807 MOBILE. (787) 644-9425
AZUCENA STREET 100
ESTANCIAS DE LA FUENTE
TOA ALTA, PUERTO RICO 00953
Page 6 of 7
ANGEL L. RIVERA ROMEU
e-mail: angelrivera.romeo@gmail.com
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Laboratory Systems / Analytical Training:
Chemist Certification Program, Drew University at Madison New Jersey; Manufacturing Certification in
Biotechnology, IVY Tech at Bloomington Indiana; Millennium and Peak Pro Data Acquisition Software
Academia, Water LC Troubleshooting & Maintenance School, HP1050, 1090 & 1100 LC Systems
Troubleshooting & Maintenance School, Knowledge in LIMS and LAN, Advanced Dissolution Course,
Near Infrared Applications and others.
ANALYTICAL TECHNICAL SKILLS_________________________________________________________
High Performance Liquid Chromatography (HPLC), SPC for Manufacturing Applications, Gas
Chromatography (GC) with Head Space Applications, Fourier Transformation IR (FTIR), UV-VIS
Spectrophotometer, Atomic Absorption (AA), Karl Fischer and Automatic Titration, Dissolutions Systems,
Total Organic Carbon Systems (TOC) and Differential Scanning Calorimeter (DSC) to determine Drugs
Crystals Polymorphs and Drug Conformation Arrays. Knowledge in Automated Cleaning In Place (CIP)
Skids.
EDUCATION__________________________________________________________________________
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May 1992 – BS in Industrial Chemistry
University of Puerto Rico, Humacao Campus
Puerto Rico Licensed Chemist (3706)
Ex-member of the ACS, Puerto Rico Chapter
Member of the Puerto Rico Chemist Association
COMPUTER SKILLS____________________________________________________________________
Windows Office Software Applications, Microsoft Office and Power Point
LANGUAGES AND REFERENCES________________________________________________________
English and Spanish. References will be furnished upon request.
HOME (787) 251-8807 MOBILE. (787) 644-9425
AZUCENA STREET 100
ESTANCIAS DE LA FUENTE
TOA ALTA, PUERTO RICO 00953
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