Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Leyda Espinosa

Urb. Ext. Villas De Buenaventura #593,Yabucoa, PR

Summary

Quality oriented professional with over 20 years of extensive experience in Pharmaceutical industry. Vast experience in CAPA Systems, Internal and External Auditing, Documentation, Deviation Investigations, Regulatory Inspections, Product Quality Complaints and Project Management. Manufacturing regulatory compliance knowledge (i.e. GMP 21CFR parts: 11, 58, 211, 820 and ICH Q7, Q9 and Q10; ISO ruling and IPEC requirements for suppliers. Leading successful Product Quality Complaints program, optimization global projects, internal and external audits and readiness process for regulatory inspections. Fully bilingual in English and Spanish. Proficient in Microsoft Office, SAP, Infinity, and others.

Overview

25
25
years of professional experience
1
1
Certification

Work History

Manager Compliance

Bristol Myers Squibb Manufacturing Company
01.2015 - Current
  • Assures the site quality systems are in place to avoid any possible regulatory compliance situation at the Site.
  • Manages the different quality systems and programs established at the site such as but not limited to Change Control, Product Quality Complaints, Self-Inspection Audits, Document Control, External Audits, Quality Agreements, Supplier Qualifications, Annual Product Quality Review, Site Inspection Readiness, and others as assigned.
  • Prepares Annual Product Quality Reviews report for each pharmaceutical finished packaged and bulk drug products manufactured at the Site as per established timelines.
  • Conduct audits to suppliers and GMP Services Providers in support of the Supplier Management Program
  • Reviews and prepares regulatory documentation intended for government regulatory agencies (e.g. FDA), such as site master files, new and existing product registrations, regulatory submissions, foreign countries registrations, certificates, etc.
  • Reviews, evaluates and approves plant operating documents such as SOPs, change control, qualification reports, Protocols, CAPA, and process deviation investigations and maintains documents in an organized and traceable manner.
  • Evaluates specifications, documents, protocols, registrations and recommends actions to assure regulatory compliance.
  • Provides assistance in managing all aspects of regulatory and corporate inspections and participates actively during inspections and audits including performing readiness exercises before and during inspections/audits.
  • Evaluates and recommends lots to be placed on stability, evaluate trends, and performs investigations when required.
  • Ensures compliance with procedures, policies and directives to avoid regulatory issues performing Gap Analysis on BMS documents and observational findings from the pharmaceutical industry.
  • Provides advice and service to all operating departments to assure compliance with cGMP’s and other regulations.
  • Investigates product quality complaints, issues the corresponding reports indicating possible root cause and recommending solutions.
  • Conducts and/or prepares training materials on GMP topics.
  • Conducts formal Self-Inspection audits and pre-approval inspections following annual site plan with respective reports and actions items from areas impacted during the audit. Ensures the site has a self-inspection audit program and that all system audits are conducted at a specified frequency. Create, review approves and track corrective actions related to Self-Inspections and external audits
  • Generates, reviews and implements procedures and forms to assure compliance with current practices and GMP Trends.
  • Provide guidance and support on the transfer and introduction of new products and processes to the site to maintain quality and compliance.
  • Coordinate Fact Findings documentation following Global Quality requirements
  • Support issuance of NDA Field Alert Reports and recall investigations.
  • Provide support in the preparation of the monthly Quality Council Meeting, including support to gather and / or calculate metrics.
  • Develops impact assessments related to Policies and Directives implementation. Ensure Global Quality policies and procedures are implemented in a timely manner, following pre-established schedule.
  • Ensures that all current vendors are qualified and conduct audits of approved vendors at defined frequencies as part of the vendor monitoring process as part of the Supplier Management Program.
  • Create, evaluates, follow up and approves change controls, including interactions with Global support areas, other BMS sites and third parties. Ensure change controls are created according to local SOPs and Global Quality requirements. Provide input into change control program management to assure all requirements to complete a change control are properly established and that no requirements are missing.
  • Provide support to local and global projects, act as liaison for regulatory activities and provide guidance for gaps identified and determine potential remediation activities.

Chemical Laboratory Coordinator

Bristol Myers Squibb Manufacturing Company
05.2006 - 01.2015
  • Review analytical data for compliance with GMP’s, internal Company Policies and Testing Standard.
  • Verify and assures the due dates completion of laboratory testing schedules.
  • Coordinate the laboratory work and testing priorities to maintain the work schedule according to the established business priorities with Material Management, Laboratory, Product Release and Manufacturing.
  • Perform laboratory investigations, validations reports and other technical reports.
  • In charge of the Chemical Laboratory during the absence of the Laboratory Supervisor reporting to the Laboratory Manager
  • Participate on Release Attainment Meeting.
  • Train Lab Analyst on procedures, laboratory techniques and instrumentation.
  • Develop new ideas to improve laboratory efficiency and cycle time reduction.
  • Monitor the performance of the laboratory in order to comply the customer service standards and achieve cycle time reductions.
  • Predict and prevent problems within the area of responsibility.
  • Prepare laboratory metrics and reports.
  • Participate during regulatory inspections.
  • Prepare the APQR laboratory report.
  • Improve Laboratory Analytical Methods and SOP’s.
  • Perform QC Laboratory internal audits.
  • Evaluate laboratory investigations to prevent recurrence.
  • Participate on Human Error Reduction Program.

Chemical Laboratory Analyst (QC Laboratory)

Bristol Myers Squibb Manufacturing Company
05.2003 - 05.2006
  • Perform all Chemical and Physical analysis of Raw Materials, Finish Products, Tablets and Capsule, and Solvents to determine Potency and Impurities using HPLC, GC and Dissolution.
  • Raw Materials analysis by IR, KF, NIR and wet chemistry.
  • Troubleshooting of analytical equipment like HPLC and GC.
  • Equipment Calibration.
  • Training of new personnel.
  • Developed new ideas and suggestions to improve laboratory efficiency.

Shift Laboratory Analyst (In-Process Laboratory)

Bristol Myers Squibb Manufacturing Company
06.1999 - 05.2003
  • Monitoring process reactions.
  • Analyze decontamination samples (Rinses and Swabs).
  • Memos and VCCF Generation.
  • Method Validation.
  • Laboratory Inspections.
  • Standards Inventory.
  • SOP and Laboratory methodology write and review.
  • Protocol Validation and Report Validation.
  • Verification of Laboratory Documentation.

Education

Bachelor of Science - Industrial Chemistry

University of Puerto Rico
Humacao Campus
05.1999

Skills

  • Strong knowledge in cGMP’s, GLP’s and FDA Regulations
  • Technical writing and interpretation skills related to investigations, process & equipment validations/qualifications, computer system validations, Regulatory Filings, and customer complaints
  • Knowledge of CAPA system management, investigations, deviations and documentation management
  • Compliance Monitoring
  • Audit management
  • Regulatory expertise
  • Advanced knowledge of computer software: Empower, LIMS, Trackwise, SAP and Infinity System
  • Computer Skills: Microsoft Office (Outlook, Word, Excel and Power Point)
  • Teamwork oriented
  • Excellent written and oral communication skills in Spanish and English
  • Use of USP, EP, JP and BP Pharmacopeias
  • Current Good Manufacturing Practices
  • Capable of managing multiple tasks simultaneously

Certification

  • ASQ-CQA
  • Yellow Belt Certification
  • Executive Presentation Skills

Timeline

Manager Compliance

Bristol Myers Squibb Manufacturing Company
01.2015 - Current

Chemical Laboratory Coordinator

Bristol Myers Squibb Manufacturing Company
05.2006 - 01.2015

Chemical Laboratory Analyst (QC Laboratory)

Bristol Myers Squibb Manufacturing Company
05.2003 - 05.2006

Shift Laboratory Analyst (In-Process Laboratory)

Bristol Myers Squibb Manufacturing Company
06.1999 - 05.2003

Bachelor of Science - Industrial Chemistry

University of Puerto Rico

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Leyda Espinosa