Angel Mario Jusino Berrios is an experienced registered pharmacist with extensive experience in the pharmaceutical industry, managing consent decrees and ensuring regulatory compliance. He has held senior roles providing quality consulting services, including implementation of validation guidelines, quality system assessments, and preparation of regulatory reports. Berrios has expertise in areas such as quality system implementation, process validation, remediation programs, auditing, and technical strategies.

1. Angel Mario Jusino Berrios
Skills:
Registered Pharmacist with vast experience working for the Pharmaceutical Industry and
Managing and Resolving three (3) Consent Decrees, Guaranteeing Compliance and
Adherence to State and Federal Regulations. Experienced in Quality System
Implementation, Preparation for PAI, GMP Training, Development, Mentoring, Develop
Policy Guidelines and Procedures, Validation Review, Consent Decree Remediation, Third
Party Auditing, Corrective action Management. Knowledgeable in Master Plan
Development, Facility Design, Regulatory Filing, Technology Transfer Management,
Critical System/ Utility Design and Commissioning, Technology Assessment, Vendor
Qualification.
Qualification & Regulatory Consultants Group, Inc., Caguas PR, 2015 to Present
Senior Quality Consultant
• Implementation of New FDA Validation Guidelines,
• Implement and Improve Continues verification Systems,
• Assessment to the Quality System Program,
• Perform Compliance Metrics Report
• Preparation of APR/PQR reports.
The Quantic Group, Ltd., Livingston, NJ, 2003 to 2014
Senior Consultant
• Assist Pharmaceutical Companies Worldwide to achieve satisfactory compliance on
on Regulatory matters related to Corporate integrity agreement compliance, Consent
Decree negotiations and resolution, application integrity policy audits, technology
transfer, due diligence, and product and company acquisitions,
• Design and Plan Remediation and Compliance Enhancement Programs,
• Manage Facilities / Equipment / Critical Utilities Qualification,
• Lead Development, Formulation, Manufacturing, Quality, and Technical Manufacturing
Strategies and Compliance Enhancements,
• Provide Subject Matter Expertise in Product Development, Formulation / Manufacturing
Issues, product launches Packaging, Validation, Purchasing, Production, Engineering, Medical
Devices (ISO 13485:2003 FDA Regulations) and Regulatory Audit areas,
• Conduct programs on behalf of clients in three main arenas:
Compliance: Quality System Implementation, Preparation for PAI, GMP Training,
Development, Mentoring, Develop policy Guidelines & procedures,
Validation review, Consent Decree remediation, Third Party Auditing,
Corrective Action Management.
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2. (Continuation of Quantic Group Responsibilities):
Technical: Master Plan Development, Facility Design, Regulatory Filing, Technology
Assessment, Project Management, Critical System / Utility design &
Commissioning, Technology Transfer Management, Vendor Qualification.
Strategic: Organization Design, Strategic Plan, Optimization, Business Plan, and
Product Strategy.
• Provide support to special projects including audits, assessments, remediation activities,
and investigations related to Consent Decree.
• Performed GAP assessment for existing equipment and process validation packages as
part of the remediation activities performed in Schering Plough, GSK, McNeil Healthcare,
Bard Shannon and Quantic Group.
• Responsible for the development of policies, employees requirement profiles, marketing
strategies, business development, clients relationship as well as provide direct support to
clients in the validation and manufacturing areas.
• Participates in the preparation of the Chemistry, Manufacturing and Controls (CMC)
section of the Regulatory Submission.
• Other client support has included: Project Manager for new sterile product facilities;
Start-up coordination of activities between the contractors, suppliers, Engineering,
Validation QA, QC, Regulatory, and Planning/Materials Departments.
• Project Management of Validation Requirements related to Construction or Expansion
Projects.
ISS Corporation, Hato, Rey, Puerto Rico, 2002 to 2003
Division Manager
• Responsible for the overall client - company relations, resource management, project
coordination, project delivery, senior consulting services in regulatory and validation
areas.
• Supervise engineers and other resources, including all managerial responsibilities, i.e.
recruiting, mentoring, conflict resolution, personnel assignment, preparation of budget for
projects, supervision of department budgets.
• Responsible of Puerto Rico Operations business planning and administration.
• Assist the ISS President with clients and internal administration.
• Keep up to date with latest CGMP concerns & changes, know FDA concerns.
• Set standards for quality of work, including documents, CGMP audits, site visits,
consulting, etc. Set uniform procedures & standards.
• Present CGMP requirements, document needs, and construction and Validation concerns
to validation project managers and validation staff.
Solgar Vitamin and Herb, 1997 to 2001
Regulatory Affairs & Validation Consultant
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3. • Oversee implementation of projects, including management and conflict resolution.
• Design and Development of Change Control Program.
(Continuation of Solgar Vitamin and Herb Responsibilities):
• Design and Prepare Validation Protocols.
• Manage Validation Projects, Technology Transfer, and Process Optimization.
• Conduct and Implement Validation Programs with joint efforts from Production and
quality Assurance.
• Prepare Qualification protocols for Computerized Systems.
• Design and Implementation of the Cleaning Validation Program.
LG Scott Associates, San Juan, Puerto Rico, 1996 to 1997
Department Manager
• Supervise engineers assigned.
• Responsible of Puerto Rico Validation Operations business planning and administration.
• Responsible for the overall client - company relations, project coordination, project
delivery, senior consulting services in regulatory & validation areas.
• Handle all administrative responsibilities of a Validation Department Manager. These
include but are not limited to, recruiting, personnel conflict management, personnel
assignment, preparation of budget for projects, supervision of department budgets.
Syntex Pharmaceutical, Inc., Humacao, Puerto Rico, 1993 to 1996
Senior Validation Technologist
Manage Validation Projects, Technology Transfer (PAI team member), Process
Optimization.
Conduct and Implement Validation Programs with joint efforts from Production and
Quality Assurance.
Prepare Validation Master Plans for existing and new facilities.
Design and Prepare Validation Protocols.
Prepare Qualification Protocols for Computerized / Automated Systems.
Design and Development of Change Control Program.
Design and Implementation of the Cleaning Validation Program.
Eli Lilly Industries, Inc., Carolina, Puerto Rico, 1990 to 1993
Senior Validation Representative
Validate all Pharmaceutical Processes of three manufacturing plant (dry-product, solid
dosage, capsules, oral suspension, vaccine and sterile area).
Provide Validation and Regulatory expertise to the Maintenance and Engineering areas,
especially in the Preventive Maintenance, Calibration of Equipment, and System
Certification.
Qualify and validate all Finishing Lines, related Equipment and Label Control Area.
Facilitated, coordinated, scheduled and assisted facility and process validations. This
includes steam sterilization, cleaning validation, media fills, and validation of particle and
cosmetic inspection machine for parenteral products. Coordinated the execution of the
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4. Plant Validation Master Plan. Developed and reviewed validation protocols and reports.
Recruited, trained and supervised validation staff.
(Continuation of Eli Lilly Responsibilities):
Improved the validation process for a Stopper Washer and Controlled Environmental
Chambers by purchasing and using wireless thermocouples allowing the machine to be
tested in normal operation. Improved the validation for stoppers by including colored
stoppers in the wash and sterilization cycle, recovering inoculated stoppers at the end of
the cycle.
Performed two factory acceptance tests in Japan and validated two particle and cosmetic
inspection machines for vials. This resulted in a faster and problem free validation.
Prepare Process Validation protocols and monitor process validations for biological products
filled in ampoules or vials using a Bosch filler/sealer and Lyophilized in a BOC Edwards freeze
dryer.
Development Procedures and Protocols for Bulk Processes & Cleaning Validation.
Rorer Pharmaceutical Corporation, Manati, Puerto Rico
Manufacturing Section Manager, 1989
Responsible for all Phases of Manufacturing Management which include:
Scheduling and Coordination of Production.
Review and Preparation of Procedures.
Organization and Operation of New Departments.
Optimum Utilization of Manpower and Equipment.
Recommends and Implements High Technology Projects to Automate Manual
Manufacturing Operations.
Supervise Manufacturing Personnel (two supervisors and four section- leaders).
Control of a Multi-million Annual Plant Budget.
Experience in Solid Dosage forms, Liquids, Capsules and Creams.
Product Improvement Pharmacist, 1988 to 1989
Troubleshoot the Manufacturing, Packaging and Engineering Departments in changes of
existing Equipment and Utilities.
Supervise the Instrumentations Section Program of the Pharmaceutical Services
Department.
Development and implementation of the Validation Program in accordance with
Corporate Validation Policy.
Interact with Fort Washington Validation Department to prepare Protocols and provide
any necessary documents to Validate Process and Qualify Equipment.
Zenith Laboratories Caribe, Inc., Cidra, Puerto Rico, 1985 to 1987
Technical Services Specialist I, 1985 to 1987
Coordinate GMP and Safety training Sessions for all Personnel.
Technical advice to Production and Quality Control areas:
GMP's and SOP's Audits / Validation of Processes
Equipment and Products / Special Projects
Documentation of any Process of procedural changes.
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5. (Continuation of Zenith Laboratories Responsibilities):
Production Supervisor, 1984 to 1985
Supervised Manufacturing personnel (granulation, milling and blending).Assisted the
Production Manager with: Granulation, Coating, Blending, Compressing and Capsule
Filling Manufacturing Process Schedules.
Stressed adherence to written procedures and to all Safety, Health, Security and Personnel
Regulations.
Assisted in the Periodic Evaluations of Subordinates.
Coordinated and presented GMP and Safety Training Sessions with Personnel
Department as needed for area of responsibility.
Roche Products, Inc., Manati, Puerto Rico, 1981 to 1984
Quality Assurance Auditor III
Ensure and monitor all product quality features.
Ensure that the weigh, blend, compress, coat & print areas perform all responsibilities
involved in the manufacturing process.
Supervise and support the sampling inspector.
Verifications of batch records and packaging order documentation.
Implemented a sampling system for: collection, identification and record keeping.
Education
Bachelor of Science Degree, Pharmacy, 1980
University of Puerto Rico/Rio Piedras Campus.
Registered Pharmacist # 3159.
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6. (Continuation of Zenith Laboratories Responsibilities):
Production Supervisor, 1984 to 1985
Supervised Manufacturing personnel (granulation, milling and blending).Assisted the
Production Manager with: Granulation, Coating, Blending, Compressing and Capsule
Filling Manufacturing Process Schedules.
Stressed adherence to written procedures and to all Safety, Health, Security and Personnel
Regulations.
Assisted in the Periodic Evaluations of Subordinates.
Coordinated and presented GMP and Safety Training Sessions with Personnel
Department as needed for area of responsibility.
Roche Products, Inc., Manati, Puerto Rico, 1981 to 1984
Quality Assurance Auditor III
Ensure and monitor all product quality features.
Ensure that the weigh, blend, compress, coat & print areas perform all responsibilities
involved in the manufacturing process.
Supervise and support the sampling inspector.
Verifications of batch records and packaging order documentation.
Implemented a sampling system for: collection, identification and record keeping.
Education
Bachelor of Science Degree, Pharmacy, 1980
University of Puerto Rico/Rio Piedras Campus.
Registered Pharmacist # 3159.
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