Meet Yvette @ Lean Enterprise Consulting Inc.

Professional Summary:

Dedicated professional, eager to provide services in general Quality Systems, using knowledge acquired during 25 years of service to regulated environments: Pharmaceuticals, Medical Devices, Biotechnology, Nutrition and Cosmetics companies. Skilled in multiple areas: regulatory compliance audits, non-conformance/CAPA/SCAR investigations, product quality reviews, suppliers quality and qualifications, training systems, purchasing controls, production planning, writing procedures, GMP, GLP, Human Error Prediction and root cause investigations. Willing to travel as required.

Skills and Knowledge:

·      Compliance Management

·      Experienced Auditor

·      Train the Trainer

·      Human Reliability Certification

·      Fully Bilingual – English and Spanish

·      Excel, PowerPoint and Words Proficient

·      MDSAP

·      21 CFR Parts: 820, 58, 210, 211, 206 and 207

·      ISO 13485, ISO 9001, ISO11135 and ISO 17025

·      Fast learner

·      Team Player

·      Natural Leader

·      Self-starter

·      Organized

·      Responsible

·      Reliable

·      Trustworthy

·      Able to work with minimum supervision

Experience:

April 2017 to March 2018: Oscor, Inc. Palm Harbor, FL

Quality Systems Compliance Manager for Oscor, Inc. Palm Harbor, FL, and Oscor Caribe, Santo Domingo, DR.

Develop and implement Internal Audits program. Develop a Hosting Audit program and support front room and back room for Regulatory Bodies Inspections.   Develop Internal Auditors Academia and conduct internal auditors training.  Support the Develop training program and support GMP training activities company-wide. Develop new procedures for Good documentation practices and support revision of existing procedures in alignment to meet ISO13486:2016 and MDSAP requirements. Initiate ISO13485:2016 and ISO11135:2014 certifications for both sites and MDSAP certification process for Palm Harbor site. Conduct Internal Audits for both Oscor sites against ISO13485:2012, ISO13485:2016, ISO11135:2014. Investigate and implement Corrective Actions and Preventive Actions for Internal Audits system and other Quality Management Systems. Review and approve Internal Audit CAPAs.

Jan 2017 to April 2017: Oscor, Inc. Palm Harbor, FL ( Lean Enterprise Consulting, Inc.)

Remediation for Warning Letter Medical Device – 21 CFR Part 820 and ISO13485

Provide customer with consultancy and remediation support on CAPAs and Non-Conformances. Support for FDA inspection. Provide consultancy to develop the Suppliers Qualification program.

Aug 2014 to Jan 2017: Quality Auditing LLC (ISO and FDA Quality Systems Specialists) Puerto Rico Area

                        Lead Auditor – Contractors

Provide Lead Auditing Services upon request to local Puerto Rico corporations against ISO:9001, ISO: 13485 and IPEC Current Distribution Practices.

December 2016: Samsung, South Korea

Auditors Workshop and Train the Trainers for Auditors

Provide Auditors workshop and Auditors Train the Trainers session using as base regulatory standards 21CFR parts 820, 210, 211, EU Commission and ICH. The workshop included an overview of regulatory requirements, preparation for audits, communications and technical writing technique hints for preparing the audit reports.

June 2013 to December 2016:

Quality Advisor / Senior Consultant

Provide Human Reliability consultancy, site assessment and training to a variety of regulated companies in USA, Canada, Europe, and Singapore. Provide guidance and recommendations to predict and avoid human errors, identify human errors root causes and implement proper corrective actions.   Provide training and develop procedures using Human Error reduction techniques. Develop and implement guidelines to reduce Human Error probabilities during Batch Record Reviews and during Line Clearance process.

 

June to September 2016 – TEVA-RIMSA, Guadalajara, Mexico (Service through PAREXEL)

Quality Systems Auditor and Product Quality Reviewer

Provide auditing services, data integrity assessment and product quality review to all quality systems against Mexican Norm 059, 073 and 164. Record reports.

June 2012 to May 2013: Ben Venue Laboratories, Bedford, Ohio, USA. 

Consent Decree – Training Compliance Planning and Quality Expert – Consultant

Develop and implement a Site Training Master Plan. Design and conduct an Investigations Training Boot Camp. Design guidelines for the Site-Wide On the Job Training Program. Conduct Job Analysis and Task Criticality Assessments to multiple departments. Develop Mentorship Program for production employees. Assess production employee’s qualifications, identify discrepancies and provide guidance to meet regulatory compliance requirements.

Sep 2011 to June 2012: Amgen – Juncos, Puerto Rico 

Validation and Compliance – Documentation Reviewer

Review post executed validation protocols and technical reports to ensure the accuracy of data against Good Documentation. Resolve discrepancies with validation owners.

Sep 2010 to Sep 2011: Johnson & Johnson – San Cristobal, Dominican Republic 

Quality Systems Consultant

Remediate Non-Conformance system.  Develop Non-Conformance Material Handling Procedure and associated forms. Support the development and conduct training plant wide on “How to conduct Non-Conformance Investigations”. Enforce the use of Risk Management approach to Non-Conformances investigations, CAPAs and Internal Audits.  Assist customer throughout a Corporate Audit, pre-audit preparation, backroom assistance and post audit task planning.

2005 –Jan 2010 Roche Operations Ltd – Ponce, Puerto Rico

QA Department – Suppliers Management Consultant

Develop the Suppliers Qualification Program. Qualify direct goods, indirect goods, and direct service suppliers. Monitor and report supplier’s performance. Execute supplier’s quality audits. Submit Suppliers Corrective Action Requests (SCARs) and guide suppliers through its implementation and verification of effectiveness. Support suppliers change to assure regulatory compliance and internal company requirements. Initiate investigations support implementation of corrective actions for raw material non-conformances identified on-site. Validate and implement SAP Purchasing Controls Modules, develop corresponding procedures and provide plant-wide training.

2003 – 2005        Roche Diagnostics Puerto Rico – Ponce, Puerto Rico

QA Department – Product Support Specialist

Lead processes and products event and non-conformance investigations and determination of root cause and CAPA implementation. Lead the validations program as the “Chairman” and final decision taker through the evaluation, development and final approval of the validation protocols (IQ / OQ / PQ). Support, coordinate and document the Customers Complaints investigations to support Roche Diagnostics Indianapolis Customers Inquiries Department investigations.

1999 – 2002       Corange International – Ponce, Puerto Rico

Materials and Logistics Department – Planner Buyer

Plan and schedule manufacturing areas. Purchase raw material. Coordinate raw materials logistics and on time deliveries. Schedule preventive maintenance activities, support new processes and process change. Implement JIT (Just in Time), support Lean Manufacturing activities and support low inventory initiatives to maintain the business competitiveness. Support EHS safety and environmental audits.

1996 – 1998       Corange International – Ponce, Puerto Rico    

QA Department – Chemistry Laboratory Analyst

Develop laboratory procedures, support problem solving, special projects, equipment troubleshooting, and laboratory (OOS) investigations. Maintain laboratory supplies and reagents inventory. Perform final and raw material testing. Review and approve laboratory reports. Develop and executes IQ, OQ and PQ protocols and transfer methods. Primary techniques used were UV-Vis Spectroscopy and HPLC, IR, KF, Potentiometric Titrators.

1994 – 1995       Ayers Wyeth Pharmaceuticals – Guayama, Puerto Rico

QA Department – Microbiological Laboratory Technician

Perform Microbial-related testing to production water, raw material, in-process products, finished product and stability products. Execute productions equipment cleaning validations sampling and microbial testing. Other duties also included: the use of aseptic techniques, sanitization practices, sampling and plate’s inoculation, microbial standards development, gram positive/negative bacteria identifications.

1991 – 1993       Ayers Wyeth Pharmaceuticals – Guayama, Puerto Rico

QA Department – Chemistry Laboratory Analyst

Perform laboratory-related testing and data entry to LIMS systems. Perform raw material, in process and final testing. Primary techniques used were UV-Vis Spectroscopy and HPLC, IR, KF, Potentiometric Titrators. Review and approve laboratory records, support problem solving, special projects, equipment troubleshooting, laboratory investigations, maintain laboratory supplies and reagents inventory.

Education:

1987 – 1991        Pontifical Catholic University of Puerto Rico, Ponce PR, BS Chemistry

Affiliations/Certifications

  • Human Reliability Certificate (2012)
  • Train the Trainers Certificate (2012)
  • Lead Auditor Certificate (2004)
  • ISO 9001:2000 Lead Auditor Certificate (2004)
  • ISO13485:2003 Lead Auditor Certificate (2005)
  • Several certifications and training from DDI’s Learning Systems, Developmental Dimensions Inc. including: “Conflict management”, “Giving Feedback” among others
  • Licensed Chemist since 1991, Chemist College of PR Member, License # 3585

For more information and availability of this SME, please contact:

Dr. Thomas Agrait

Lean Enterprise Consulting Inc.

Email: tagrait@gmail.com

Tel : (954) 258-3117