Bello Biophar Consulting Corp

Servicios de Consultoria y por Contrato. Contamos con profesionales con mas de 20 años de experiencia.

Cuenta con Profesionales experto en Sistemas de Calidad:

  • Investigation System
  • Annual Product Review System
  • Complaints System
  • Validation System
  • Media Fill Program
  • Personnel Qualification Program
  • Trainng Program
  • Consent Decree Management
  • Cleaning Validation Programs
  • 100% visual Inspection Program, 

Sistemas de manufactura:  

  • Manufactura de Parenterales, Liquidos y Soidos.
  • Aseptic Filling,  Stoppers and Equipment Preparation and Sterilization,
  • Vial Washing and Sterilizaton
  • Lyophilization cycles
  • Terminal Sterlization
  • Autoclave cycles, 

Protocols developement for employee's skills assessment, Competency Assessment

  • Requerimientos Regulatorios para la manufactura de Productos Parenterales y productos Biológicos
  • Requerimientos Regulatorios de construcción de sistemas de agua y aire.
  • Diseño de Batch Records
  • Plan de Adiestramiento para Operadores, Supervisores y Managers
  • Diseño del Quality Plan
  • Revisión de Investigaciones para cumplimiento regulatorio.
  • Requerimientos de validación de Equipos y de Procesos.
  • Programa de Change Control
  • Diseño Organizacional
International, USA and PR Services.
787-217-9606  Bello BioPhar Olga López                               

Olga María López

Apartamento 3606
Montecillo Court
Trujillo Alto PR, 00976

Email:

olgalopez@yogati.com

Cel:

787-217-9606

  • SUMMARY

    More than 20 years of experience in the Pharmaceutical and Biological industry. Lead managerial positions in both Manufacturing and Quality Assurance. My professional development has included positions as supervisors, manager and director in the pharmaceutical and biological industry. Has worked for Wyeth Pharmaceuticals in Carolina, PR, Wyeth Biologics, North Carolina, Lyphomed, PR, and MOVA, PR. Have vast knowledge in FDA and European regulations. Have extensive experience in various facilities startups for Parenteral, Solids and Biological products. Have received FDA approval after completion of three facilities start up, in North Carolina and in two facilities in Puerto Rico. Vast knowledge in Federal and European regulations and in the design and validation requirements for utilities and equipment.

  • EDUCATION

    Bachelor Degree in Science with concentration in Biology and Chemistry- University of PR Master Degree in Marketing-(in-process)-Inter American University of PR

  • EMPLOYMENT HISTORY

    Mar 2015 to Nov 2016
    Independent Consultant for Pharmaceuticals

    The Quantic Group, Ltd., Parexel and Quality Executive Partners at Sun Pharmaceuticals at Bangalore, RIMSA-TEVA at Guadalajara, Mexico and Unimed at Vadadora, India.

    • Quality Systems Assessments to several Quality Systems such as: Gowning and 100% Visual Inspection qualifications; Aseptic and clean area cleaning programs, Media Fill, and Training programs.
    • Revised Procedures for Labeling and Packaging, Aseptic Practices, Aseptic Filling, sealing and lyophilization.
    • Reviewed Investigations and CAPA’s as part of the Batch Record review for batch disposition.
    • Developed and Executed remediation plan.
    • Inspected Manufacturing areas for adequacy of equipment and facilities; compliance of processes with Federal Regulations, compliance with company and global procedures.
    • Developed and run an employee skilled assessment program to identify employee’s skills, experience and knowledge. 
    • GMP audit to facilities and laboratories.
    • Reviewed the facilities Environmental Monitoring Program and designed strategies for improvement for locations, monitoring techniques, and reporting.
    • Participated in frequent meetings with Global Development Group to ensure procedures in all facilities were deployed timely and consistently for the implementation of new software, qualifications, and all revised programs. 
    • Developed an Aseptic Practices and Glove Integrity Testing training program based on employees, plant, FDA 483’s observations and warning letter and deployed to the three different Mylan/Agila sites.
    • Deployed training to employees and management. Revised Media Fill Batch Records, employee Media Fill qualification program, 100% Visual inspection program, Investigations, and Procedures for packaging and labeling.
    • Assessed the Microbiology Laboratory facility and testing processes to ensure compliance with Regulatory regulations, Good Laboratory Practices and Plant’s commitments.
    • Performed various lab facility and testing procedures audit until laboratory was in condition to be inspected by Regulatory Agencies. 
    • Developed flow charts for microbiology lab processes and environmental excursions.
    • Developed presentations for the Microbiology lab and Product Disposition to be presented to Regulatory Agency.

    2011- 2015

    Independent Consultant for Pharmaceuticals
    through The Quantic Group, Ltd at Pharmaceuticals at McNeil Las Piedras, Puerto Rico

    • Batch Record Quality System Assessment to ensure regulatory and commitments compliance.
    • Prepared and revised Investigations and CAPA’s.
    • Product Disposition Quality System Assessment.
    • Inspected manufacturing areas for GMP compliance.
    • Reviewed and revised Standard Operating Procedures (SOPs).
    • Revised Electronic Batch Record system implementation.
    • Assessed Annual Product Review and Complaints Programs.
    • Prepared finding reports, charts, trends, and recommendations.
    • Followed up FDA and plant commitments throughout the different Remediation plan groups: Validation, Quality Assurance, Engineering, Manufacturing.
    • Reviewed executed Batch Records for batch pre-disposition.

     

    2002 – 2010

    Director Quality Assurance, Associate Director
    Wyeth North Carolina, USA and Guayama, PR

    • Managed and led the Quality Assurance Department for three major products on Batch Record review, Product Disposition, Validation of Equipment and Processes.
    • Review and Approval of Annual Product Reviews, Master Validation Plans, Complaints, and Investigations.
    • Reduced investigation closing rate to 2-3 days.
    • Reduced regulatory inspection observations to zero by training the QA personnel in the manufacturing processes and by maintaining QA closely involved in the manufacturing areas. 
    • Started up a new state of the art building (In North Carolina), hired a new QA group for all QA positions.
    • Initiated the Investigations/CAPA and Change Control Program,
    • Review and approved the Project Plan, Master Validation Plan, drawings, Validation/Qualification protocols and execution.
    • Initiated a successful program for QA employee’s recognition.
    • Achieved satisfactory FDA, European, Mexico and Japan inspections.

     

    2001-2002             

    Independent Consultant
    Schering Plough at Manati, Puerto Rico, Wyeth at New York, North Carolina and Pennsylvania, USA

    • Assessed the following programs: Batch Records, Product Stability, Complaints, Investigation/CAPA and Annual Product Review.
    • Prepared reports for all assessments finding.
    • Charts progress for Complaints and Annual Product Review Programs.
    • Audited for GMP and regulatory compliance different facilities in Puerto Rico, North Carolina, New York, and Pennsylvania

    1991 – 2000
    Director Parenteral Manufacturing at MOVA Pharmaceuticals at Caguas, Puerto Rico

    • Managed and lead 16 supervisors and section heads to manage more than 100 employees in the different manufacturing areas:  Equipment preparation and Sterilization, Product Formulation, Filling of Parenteral, Final Sterilization, and 100% product inspection.
    • Managed three shifts 7 days/week, thee packaging department and the oral liquid department.
    • Prepared Investigations, CAPAs, reviewed batch records and ensure its timely completion for batch disposition.

    1989-1991

    Section Head Manufacturing of Injectable, Oral Liquids, 100% Inspection, Final product Sterilization and Packaging at MOVA Pharmaceuticals at Caguas, Puerto Rico

    • Supervised a total of 8 supervisors for three shifts in all manufacturing activities.
    • Completed two facilities validation and startups with successful FDA and European approvals.
    • In charge of batch record preparation and review, investigations and CAPAs for batch disposition.

    1987-1989            

    Parenteral Pharmaceutical Manufacturing Supervisor at Lyophomed Pharmaceuticals at Canovanas,  Puerto Rico

    • Started and completed the facilities start up and achieved successful FDA and European inspections. 
    • Supervised all manufacturing areas: Equipment cleaning and sterilization, formulation, freeze drying and filling of parenteral.
    • Prepared investigations and CAPAs and batch record review.

    1982-1987 Lederle, Carolina, Puerto Rico      
    Quality Technician to perform the sterility testing

    • Supervised the manufacturing of Parenteral products: Weighing and Formulation, Filling of Parenterals, Lyophilization and Capping.

  • CERTIFICATIONS AND MEMBERSHIPS

    PIA, PDA, Green Belt

  • SKILLS AND COMPETENCIES

    Leadership

    Conflict Management

    Time Management

    Manufacturing of Solids

    Manufacturing of Parenteral

    Supervisión

    Talent Development

    Negotiation Skills

     

    FDA:  Food and Drug Administration

    Rules and Regulations governing medicinal products in the European Union (Eudra Lex)

    cGMP: Current Good Manufacturing Practices

    OSHA: Occupational Safety and Health Administration

    Technical Writing

    Computer Skills: Excel, Word, Microsoft Power Point

    Language: Bilingual (English and Spanish)