Olga López

Bello Biophar Consulting Corp. Servicios de Consultoria y por Contrato. Contamos con profesionales con mas de 20 años de experiencia. Para contrato llame al 787-217-9606.

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                                


Resume Olga Lopez                                                        

http://yogati.com/file/profesionales/olgalopezresume1.doc  

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.

 

EDUCATIÓN

 

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 2014-Mar 2015

 

         Independent Consultant for Pharmaceuticals

         Worked at Agila/Mylan Pharmaceuticals, Bangalore India

Quality Systems Assessments for Gowning and 100% Visual Inspection qualifications; Area’s cleaning, Media Fill, and Training programs; Procedures for  Labeling and Packaging, Aseptic Practices, Aseptic Filling, sealing and lyophilization; Manufacturing area’s inspection.  Developed and run an employee skilled assessment program to identify employee’s skills, experience and knowledge.  Developed an Aseptic Practices and Glove Integrity Testing training program based on employees, plant ad FDA observations and warning letter.  Provided those training to employees and management. Revised Media Fill Batch Records, employee MF qualification program, 100% Visual inspection program, procedures for packaging

 

2011- 2014

         Independent Consultant for Pharmaceuticals

McNeil Consent Decree- Las Piedras, PR

Worked as a Quality System reviewer. Has completed the review of Batch Record for product disposition, has inspected manufacturing areas for GMP compliance, has reviewed Standard Operating Procedures (SOP), Electronic batch records requirements.  Has reviewed Annual Product Review and Complaints. Has prepared finding reports, followed up FDA and plant commitments.

  

2002 – 2010       

Director Quality Assurance, Associate Director

Wyeth Biologics, Sanford, North Carolina and Wyeth Pharma, 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.  In NC started a new state of the art building, hired a new QA group, and initiated a Change Control Program, review and approval of 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

Worked for Schering Plough, Manati, Puerto Rico and Wyeth, New York, North Carolina and Pensylvania

Auditing of Batch Records and Report, Product Stability Program Assessment and Report, Complaints Assessment and Report, and Annual Product Review Assessment and Report. Charts progress for Complaints and Annual Product Review Programs. Facilities Auditing in Puerto Rico, North Carolina, New York, Pensylvania

 

1991 – 2000        Director Parenteral Manufacturing

MOVA Pharmaceuticals, Caguas, PR

Managed and lead 16 (supervisors and section heads) in the management and administration of more than 100 employees in the different manufacturing areas:  Equipment preparation and Sterilization, Product Formulation, Filling of Parenteral, Final Sterilization, 100% product inspection and packaging. Three shift/ 7 days/wk

 

1989-1991          Section Head Manufacturing of Injectable, Oral Liquids, 100%Inspection, Final product Sterilization and Packaging

                            MOVA Pharm aceutical, Caguas, PR

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.

 

1987-1989          Parenteral Supervisor

Lyphomed Pharmaceutical, Canovanas, PR

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.

 

1982-1987          Parenteral Supervisor

                            Wyeth Pharmaceuticals, Carolina PR

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)

 

 


Resume Mariangeli Diaz
http://yogati.com/file/profesionales/resume-mariangelidiaz2016.doc

Mariangeli Díaz Salgado

15273 Westbridge Ct.

Henderson, MD 21640

M - (787) 501-4029

H - (443) 262- 8228

mariangeli.diaz@hotmail.com

 

Professional Background: 

Global Consultant with +26 years of experience in the Pharmaceutical, Biotech, Food, and Medical Device Industries. Extensive experience in Regulatory Compliance, FDA, ISO22000-2005/ISO 9001-2008/13485-2003, cGxP’s, OSHA, EPA, EHS, USP/NF, JP, EP, Quality Systems Part 210-211 & 820, Planning and Auditing, PFMEA and Risk Assessment evaluations, among others. Strong leadership skills with an analytical mind to solve quality issues. Ability to promote and maintain a high level of quality competence and staff motivation to accomplish objectives and meet deadlines.  Hands-on experience as Quality Assurance Manager, Technical Services Director, Change Control Manager, and Project Manager, with knowledge in Quality Systems, Validation, Manufacturing Operations, Product Transfer, and Regulatory Compliance programs. International work performed in USA, Dominican Republic, Mexico and Puerto Rico. Successful completion of million dollar projects through project estimate, planning, budgeting, cost control, implementation, execution and closeout. Built outstanding client relationships. Supervised, directly and indirectly approximately one hundred (100) manufacturing, quality, and validation professionals. Fully bilingual. Proficient in computerized systems such as: MS Office, Kronos, Project Management, SAP, JDE, ISOtrain, Documentum SOP System, and TrackWise System. Indian Business Visa, effective until Apr 2019.

 

Key Projects and Accomplishments

 

The Quantic Group, Ltd., Livingston, NJ,                                                                                                             2011 – Present

 Sr. Quality Leader on India sites - FDA Warning Letter Remediation

 

·         Independent third party - Regulatory Services Group

o   Quality Assurance Remediation Plan Lead

o   Establish and evolve formal QA processes, ensuring that the client follow industry-accepted best practices.

o   Oversee all aspects of quality assurance in 3 sites including establishing metrics, applying industry best practices, and developing new tools and processes to ensure quality commitments are met.

o   Act as key point of contact for all QA aspects to establish a site wise harmonization.  

o   Lead and mentor Site QA team members, as well as manage outside remediation team.

o   Develop and execute remediation protocols to full fill the sites commitments.

o   Review and evaluate performance issues with up to 10 direct reports

o   Interact with customers during meetings and visits

o   Collaborate with other Areas staff to accomplish all daily tasks on-time with a high level of quality

 

 Leader on U.S. site FDA consent Decree Remediation

 ·         Independent third party - Regulatory Services Group

o   Audit remediation activities against the Consent Decree Workplan, Quality Standards, FDA, cGMPs, applicable laws and regulations.

o   Ensure Remediation Steps comply and meet the Seven Attributes of a Quality System (Process, Procedures, Documentation, Quality Role, Organization, Infrastructure, and Metrics).

o   Review Traceability Matrix to determine which gaps, findings, 483 Observations, and CD requirements are addressed by the Numbered Step.

o   Inspect the facilities to determine if the methods, facilities and controls are operated in conformity with cGMPs, and if maintained, will continuously comply with the FDA, cGMPs, applicable laws and regulations.

o   Categorize findings and develop the respective reports.

 

·         Change Control SME - Interim Controls Group

o   Provide coaching and mentoring to the Change Control Program originators and administrators.

o   Evaluate Change Controls and certify such, if in compliance, prior to quality approval.

o   Evaluated existing Change Control process and support the workshop activities.

o   Provide guidance to Quality System Teams throughout the remediation process.


o   Intervet Schering-Plough Animal Health, S.A. de C.V., Santiago de Tianguistenco, Mexico          2009 - 2011

·         Responsible of managing Remediation Project for specific product.

·         Implemented remediation activities for Manufacturing, Validation/Calibration, Quality Control, Quality Assurance, Quality Management and Warehouse areas.

·         Supervised and provided management and technical support to seven (7) Validation Engineers.

·         Scope includes manufacturing batch record review, standard operating procedures, validation activities (Installation, Operational and Performance Qualification) for manufacturing and quality control systems.

·         Provided Technical and Quality support to the organization.

 

o   Glaxo Smith Kline, Cidra, Puerto Rico                                                                                                                  2006 - 2008

Managed and developed Compliance Programs under FDA Oversight, per Consent Decree requirements.  Compliance Programs consisted of:

 o    Regulatory Compliance-Quality Management Team Leader

·            Developed and Implemented Engineering Service Providers Program.

·            Performed audits to certify suppliers and service providers.

o    Quality Standards Professional

·            Developed Periodic Product Review Program.

·            Performed data gathering and analysis of the Manufacturing Batch Records, Analytical and Microbiological Testing, Process Investigations and Costumer Complaints.

o    Product Technology Scientist

·            Developed Product Technology System.

·            Performed Product Technology Area Gap Analysis.

·            Established Remediation Plan and ensured its compliance.

·            Develop SOP’s for the system and delivered  the respective training.

·            Prepared the Product Technology Verification Binder, per Consent Decree requirement.

o    QA1 Remediation Team Coordinator

·            Coordinated 350 SOP’s Translation, Formatting, and Quality Revision.

·            Managed schedule in order to ensure Regulatory Commitment dates were met.

·            Supervised approximately 22 Technical Writers and Translators

·            Developed SOP’s Tracking System.

·            Performed SOP’s Quality Review.

·            Provided support, direction and coaching to subordinate personnel.

·            Ensured compliance with all company policies and procedures, including cGMPs and FDA Regulations.

 

 

o   Lilly del Caribe (PR05), Carolina, Puerto RicO                                                                             2004 - 2005

Commissioning and Validation Project Manager

 

·         Supervised and provided management and technical support to twenty (20) Validation professionals.

·         Managed the implementation, recruiting and management of Quality Requirements/Platform, Quality Assurance Technical and Execution Incident Teams.

·         Lead the coordination of the qualification activities.

·         Prepared project controls, budgeting, scheduling, staffing, weekly and monthly status reports, as required by the client.

·         Responsible for the staffing recruiting process and sub-contractor’s coordination.

 

o   Nypro, Dominican Republic                                                                                                                  2002-2004

Sr. Tech Transfer Director                                                                                                                

  ·         Lead the transfer activities for products from development to manufacturing.

·         Lead multi-functional Operations Transfer Teams to define and complete activities required (create specifications, test methods, manufacturing batch records, validation protocols, and reports as needed) for scale up, validation, transfer to manufacturing, and launching new products.

·         Responsible of PAI submission, post and pre-approval inspection.

·         Performed Supplier evaluation and Certification.

·         Provided regulatory guidance for top-level project development and core teams.

·         Provided support, direction and coaching to subordinate personnel in the areas of hiring, training, disciplinary action, problem resolution, work assignment delegation, and career development.

·         Wrote technical reports in support of production operations and regulatory updates (ANDA, NDA). Investigate manufacturing deviations.

·         Managed all project activities and timelines for the Product Transfer Program within the Technical Services department.

·         Managed $28-million-dollar project budget.

 

o   SCHERING PLOUGH                                                                                                                                         1999-2002

Process Certification Director                                                                                                         

 

·         Developed, implemented and executed regulatory strategic plans for the Pharmaceutical Product Re- Certification under FDA Oversight due to the Consent Decree.

·         Carried out responsibilities in accordance with the organization policies, procedures, and federal, state and local laws.

·          Developed and documented validation project plans / schedules and validation procedures based on sound validation practices and current industry standards.

·         Managed all process validation projects, activities and timelines for the Validation Certification Program within the Technical Services department.

·         Responsible for the generation and execution of process validation protocols, performance qualification protocols per related Standard Operating Procedures (SOP's). Assured the acceptance criteria related to these protocols was met.

·         Reviewed and approved validation / qualification protocols and summary reports completed by the Technical Services department and other departments.

·         Analyzed data, specifications, and basis of design or functional specifications to determine conformance with standards and established quality requirements.

·         Managed all validation personnel (13 regular and 10 consultants) and conducted performance evaluations for exempt direct reports, and assisted direct reports with subordinate performance evaluation process for their areas.

·         Provided support, direction and coaching to subordinate personnel in the areas of hiring, training, disciplinary action, problem resolution, work assignment delegation, and career development.

·         Ensured compliance with all company policies and procedures, including safety rules and regulations.

 

 

o   MDS UNLIMITED CONSULTING SERVICES CORP.                                                                                 1994 - 1999        

Validation & Quality Consultant

 

o  Validation Manager                                                                                                                   

 

·               Supervised, mentored and trained fifteen (15) junior level validation consultants.

·               Responsible of the execution and implementation of projects that supported the manufacturing operation, including projects involving marketed product development, marketed product development, marketed product support and technology transfer.

·               Accountable for the project design and coordination, including development of protocols, design of experiments, data analysis and implementation of optimized manufacturing process and qualification of alternate raw materials, excipients and components.

·               Assessed production problems at component preparation, formulation, filling, sterilization cycle and lyophilization stages by performing investigations, identifying the root causes and developing solutions.

·               Wrote technical reports in support of production operations and regulatory updates (ANDA, NDA). Investigated manufacturing deviations, Experimental and Marketed Stability Failures and Customer Complaints by following a problem solving methodology to comply with the Regulatory Agencies.

 

o  Quality Assurance / Documentation and Change Control Manager                      

 

·               Developed, implemented and maintained standard policies, procedures and controlled document systems, ensuring global level compliance with current good manufacturing practice regulations.

·               Responsible for harmonizing document control procedures throughout the corporation.

·               Participated in companywide projects that heavily impacted existing or proposed controlled documentation and provided facilitation to the project members, to ensure timely completion of these documents.

·               Managed off-site storage and retrieval of controlled documents.

·               Assisted in the development and implementation of document retention policy consistent with corporate policy.

·               Managed the corporate electronic document management system (BEN).

·               Managed all controlled document archives at manufacturing sites.

·               Developed and implemented a program for electronic documentation archiving.

·               Provided mentoring on general Quality Assurance systems/procedures (deviation systems, CAPA, etc.).

·               Gave technical support to Manufacturing Operations in different business units including: Dermik, Aerosols, and Solid Dosage.

·               Evaluated and improved the manufacturing documentation processes. Utilized statistical process control and other tools to assess the performance of the process and implement specific actions to enhance control and achievement of specifications.

 

o  Pharmaceutical Technologist Scientist

·               Wrote technical reports in support of production operations and regulatory updates (ANDA, NDA). Investigated manufacturing deviations, Experimental and Marketed Stability Failures and Customer Complaints by following a problem solving methodology to comply with the Regulatory Agencies.

·               Provided scientific technical support to Manufacturing, and lead the Technology Transfer Process.

·               Acted as a manufacturing technical liaison between Company Headquarters and other sites. Assured that the scale up of products from R&D or products transferred from other sites were accomplished with minimal confusion and disruptions.

·               Wrote, executed and coordinated protocols for process, holding time and cleaning validation. Wrote Working Formula Procedures.

·               Troubleshoot manufacturing problems and provide solutions to day to day incidents and problems. Perform statistical evaluation of process variables. Interpret data, information and regulations.

·               Utilized project management skills to ensure timely and successful completion of assigned projects. Provided training to production personnel in new technologies.

·               Managed all validation personnel (13 regular and 10 consultants) and conducted performance evaluations for exempt direct reports, and assisted direct reports with subordinate performance evaluation process for their areas.

·               Provided support, direction and coaching to subordinate personnel in the areas of hiring, training, disciplinary action, problem resolution, work assignment delegation, and career development.

·               Ensured compliance with all company policies and procedures, including safety rules and regulations.

WARNER LAMBERT, INC                                                                                                                                1988 - 1993

Compliance Coordinator                                                                                                                   

 ·               Audited Manufacturing Areas to assure GMP's Compliance, ISO 9000.

·               Developed the Supplier Certification Program.

·               Developed the Compliance Certification Plan, according to the FDA requirements.

·               Audited and Approved Validation Protocols (IQ, OQ, PQ, Computer and Cleaning Validation).

 Education and Professional Development

 BS, Science Microbiology, Interamerican University of Puerto Rico 



 

 

 

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