056

Professional Experience:

Technical Writer Dec 2020

Sr. Auditor (Pharmaceutical Supplier) Dec 2020 - Feb 2021

Lead/ Sr. Auditor (Pharmaceutical) July - Sep 2020

Lachman - Sr. Associate Consultant (Asia Pharmaceutical)                 Dec 2019 – Feb 2020

• Provide support on FDA Warning Letter responses
• Review/write Investigations/CAPA
• Review Lot records
• Mentor on Investigation (Lab/Manufacturing)
• Mentor on Good Analytical Techniques

Lachman - Sr. Associate Consultant (Asia Pharmaceutical) August- Oct 2019

• GMP Remediation support for Consent Decree 
• Review and mentor on Investigations/CAPA’s
• Review and mentor on Quality SOP’s

Sr. Consultant for API Pharmaceutical (Asia Confidential) June/July 2019

• Provide support on FDA Warning Letter responses
• Review protocols for quality activities
• Provide mentoring on setting specifications and methods validation
• Perform Data Integrity Assessment and review /mentor on Investigations

Sr. Consultant for Medical Devices Company (Confidential) May -June 2019

• Review program for Methods Verification and Validation
• Perform Gap Assessment on Test Methods Validation
• Provide QC GMP Support

Lachman - Sr. Associate Consultant (Asia Pharmaceutical)                           Dec 2018-Jan 2019

• Support responses to FDA 483 Observations
• Perform assessment to Cleaning Validation Program
• Support on Methods Validation, Investigations and CAPA’s

Validant - CAPA SME and Lead Auditor (Mexico Medical Devices)                                         Nov 2018 -Dec 2018

• Mentor, review and train on CAPA process

• Perform manufacturing and quality assessments  (Data Integrity)

• Support on FDA pre-inspection                                                                                  

Lead GMP Auditor (USA Pharmaceutical - Confidential)

• Conduct contract manufacturing audit (Aseptic Manufacturing) Sep 2018

Sr. Quality Consultant (Asia Pharmaceutical – Injectables/Solids Confidential) April – June 2018 

• Conduct Quality Gap Assessments (Laboratory/Manufacturing), including, e.g. calibration, lab data integrity, process and cleaning validation
• Deliver trainings, e.g. Technical Writing, Data Integrity, Quality Risk Management, Good Documentation Practices
• Support Investigations from Laboratory / Manufacturing / Engineering
• Assess Laboratory data integrity
• Review lot records

Lead GMP Auditor (German Pharmaceutical - Confidential)       Feb 2018

• Conduct contract manufacturing vendor audit (Aseptic Manufacturing)

Sr. Quality and Compliance Consultants                                                                                         Nov 2017- Jan 2018   

• Home-based - write/review SOP’s for Laboratory, Manufacturing and Engineering (calibration, maintenance, protocols for process validation, CAPA’s and investigations (aseptic processes)                                                                     

Lead GMP Auditor (USA Pharmaceutical - Confidential)                                                           Aug 2017 

• Conduct contract manufacturing facility audit (Aseptic Manufacturing)

Regulatory Compliance Associates (RCA)-Sr. Quality Consultant (USA Pharmaceutical)       July 2017 

• Support FDA 483 Observations and Warning Letter Responses 
• Quality System /Process and Cleaning Validation Assessments
• CAPA and non-conformances
• Development of GMP Remediation Plan

Sr. Quality and Compliance Consultant at Neopharma (solid dosages)                                Feb 2017 – May 2017

• Develop strategies for methods development and validation 
• Provide support to new product development (ANDA, technical and GMP)
• Provide training on Technical Writing, Methods Validation, Investigation / CAPA
• Conduct Quality Audit, including laboratory data integrity

Sr. Quality and Compliance Consultant, PR                                                                                 Oct 2016 – Nov 2016

• Home-based support on Quality Systems (e.g., SOP’s, CAPA’s, complaint investigations, test methods and general cGMP mentoring)
• Write and review annual product reports
• Review lot records

Ethicon, (Medical Devices), Cornelia, GA                                                                                     June 2015 – Dec 2015   

Project Manager / Scientific Leader

• Support site on GMP remediation 
• Perform assessment of Quality and Laboratory Systems (including data integrity)

• Work on CAPA’s (validation of analytical and physical test methods) development/validation/ (6 SME’s team), Laboratory practices, training and general GMP support on investigations and CAPA’s 
• Provide mentoring on ISO 13485 and 14971 and GMP
• Support cleaning, process validations, investigations, instrument calibration and maintenance for Combo products
• Perform Investigations (Mfg and Lab)

Zimmer (Medical Devices), PR                                                                                                      April 2015 – May 2015 

SME on Qualification/Validation and CAPA Coach 

• Support site on GMP remediation 
• Perform CAPA/investigations, evaluation of Equipment and Process Validation documentation 
• Mentor Management on CAPA, cleaning/process validation and general GMP support

McNeil (J&J), PR                                                                                                                           Nov 2014 – March 2015 

Coach on CAPA’s / Investigations– Solid Dosages

• GMP Remediation support for Consent Decree 
• Perform assessment of laboratory operations and laboratory analytical test methods 
• Provide coaching on CAPA / Investigations 
• Conduct/review investigations (manufacturing and laboratory)
• Collaborate with Corporate with on CAPA’s and related standard operating procedures  
• Prepare / Review Change Controls

Maquet (Medical Devices Quality Systems Remediation), Wayne, NJ                                      Jan 2014 – Oct 2014

SME on Investigation / CAPA

• Conduct/review investigations / CAPA’s and prepare MDR’s
• Perform gap assessment of Complaints and CAPA systems 
• Provide training on ISO 13485 and 14971, GMP, investigations/CAPA and Data Integrity
• Prepare / Review Change Controls
• Review / revise DHR’s and DMR’s 
• Work on new Quality System
• Support on validation of physical test methods and process validation

Novartis OTC Mississauga, Canada                                                                                              Sept 2012 – Dec 2013 

Lead Sr. Consultant – Solid dosages and Creams

• Conduct Quality Systems Revamping, Investigations/CAPA, Change Control, Product Quality Reports, and Method Validation / Transfer Assessments 
• Travel to supplier facilities to investigate and identify root causes and implement effective solutions 
• PQR writing and data gathering based on Health Canada requirements
• Support site on Health Canada Regulations
• Write/review annual product reports
• Conduct Investigation and CAPA
• Review lot records

Novartis Ex Lax, Puerto Rico (PR)                                                                                                Jan 2012 – Sept 2012

Project Manager (Quality Systems Remediation) – Solid dosages

• Project Manager supporting Quality Systems for FDA Remediation, Complaint Investigations/CAPA, Change Control, GMP, Method Validation Activities, Revise analytical procedures (25), Process Validation 
• Provide support on Process Validation for solid dosages manufacturing
• Perform gap assessment of Laboratory testing system
• Revise SOP’s for operation, calibration and maintenance 
• Issue / review Change Controls
• Conduct Laboratory and manufacturing investigations
• Write/review annual product reports
• Perform Quality Assessment, including data integrity)

ProCaps Colombia –Gel Manufacturing

Lead Auditor                                                                                                                                                    Feb 2012 

• Perform Audit supporting an FDA Pre-approval Inspection and support remediation (Site passed FDA Approval inspection with zero FDA observations).  Site passed the FDA pre-approval inspection

Mylan, Caquas, Puerto Rico                                   March 2012 – Sept 2012

Project Manager 

• Supporting Documentation / SOP’s system Remediation (rewrite and walkthrough of approximately 300 SOP’s)

Johnson and Johnson (Medical Devices), Dominican Republic                                               Sept 2011 – Dec 2011

Quality Systems SME and Leader in GMP Training

• Perform Quality systems remediation (e.g. Documentation System, CAPA, Non-Conformances), Training, Change Control and Personnel Mentoring. Assess and revise DHR’s and DMR’s 

• Conduct / Review Investigations/CAPA’s and batch records

• Support on test methods validation
• Support on process validation and equipment qualification 
• Deliver training on GMP and Good Documentation Practices

Stryker (Medical Devices)                                                                                                     May 2010 – Aug 2011  

Project Manager

• Perform gap assessment on Investigations, CAPA, Cleaning and Water System 
• Provide Training on Part 820, ISO 13485/14971, Technical Writing, Audits, Process Validation and Quality Systems 
• Assess Manufacturing Investigations / CAPA’s 
• Perform evaluation on finished products for Ethylene Oxide Sterilization, removal, sampling and testing 
• Support process and cleaning validation 
• Support on the improvement of the Quality System (ISO 13485)

Tapi (TEVA) – PR           API Manufacturing                                                                          Feb 2010 – Apr 2010

Sr. Auditor / Consultant                                                                                                                                

• Perform Quality Systems assessment, methods validation and support investigations and CAPA’s remediation 
• Support Process validation and equipment qualification process

Blu Caribe (Solid Dosages)       Aug 2010 – Sep 2010 

Lead Auditor

• Perform Quality and Manufacturing System assessment, including methods, process validation, equipment calibration, submissions, investigation, stability program, Change Controls, deviations 
• Subject Matter Expert on Process Validation, Quality Systems / GMPs. Support GMP remediation, Audit submission and related document for an FDA Pre-approval Inspection

Ciba-Vision (Medical Devices)                                                                                        Apr 2009 – Aug 2010  

Project Manager   - Warning Letter – GMP Remediation         

• Conduct CAPA on Methods Validation (40 methods validated, including physical methods) 

• Perform assessment of Site Laboratory system

• Support Computer System Validation and process/cleaning validation 
• Review SOP’s for instrument operation, calibration and maintenance
• Conduct/review investigations 
• Mentor site Management on GMP, provide training and general quality strategies 
• Support on the improvement of the Quality System (ISO 13485 and ISO 14971)
• Support responses to FDA 483 observations 

Patheon – Two sites, PR        Solid Dosages                                                                             Nov 2008 – March 2009 

Lead Auditor                                                                                                                                    

• Perform quality systems assessments, review investigations, complaints, and stability profiles and write gap analysis. 
• Support Lab Management on GMP/decisions.
• Review and mentor on process and cleaning validation 

Bard- Medical Devices, PR                                   March 2008 – Oct 2008

Team Leader                                                                                                                                   

• Conduct investigation and CAPA’s evaluation
• Perform Quality gap analysis and revise/translate SOP’s (ca. 150 SOP’s) 
• Mentor site Management on ISO 13485 and 14971, GMP and best practices
• Support improvement to Quality System 

Watson – Corona California, USA                 Solid Dosages                                                      March 2006 – Feb 2008

Sr. Consultant Leader                                                                                                                                          

• Assist on GMP remediation for Consent Decree 
• Perform CAPA’s / Investigations (manufacturing and Laboratory)
• Perform methods transfer, methods validation, and gap analysis, write technical report, conduct/review investigations and review GMP documents for FDA submissions, and write/review CMC sections 
• Support/enhance the stability program
• Support process validation and products transfer
• Review lot records

Bristol- Myers Squibb, PR            API Manufacturing                                                                 Nov 2005 – Feb 2006

Sr. Consultant

• Perform quality systems assessments, review investigations, complaints, and stability profiles and write gap analysis. Support Lab Management on GMP/decisions
• Perform Engineering systems audit (e.g., equipment operation, calibration and maintenance) 
• Perform processes audits (Brown Papers)

Mayne Pharmaceutical, PR           Sterile Manufacturing Facility                                               Feb 2005 – Oct 2005

Interim Quality Director 

• Remediate QC/QA Systems and keep systems in full GMP compliance. Conduct / review investigations Manage/enhance the stability program. Interact with CMO’s 
• Conduct investigations (laboratory and manufacturing)
• Write/review annual product reports 
• Support process and cleaning validation
• Train/mentor personnel on aseptic processes. Maintain the Quality Team performing while enhancing the GMP. 
• Provide mentoring on Process Validation and support laboratory and manufacturing investigations

Ely Lilly, Bristol-Myers Squibb, Stryker, Tyco, Johnson & Johnson, Bard, Baxter, PR        Jan 2005 – Feb 2005   

• Deliver trainings on Investigation, GMP’s, Technical Writing, Good Documentation Practices, ISO 14971 and ISO 13485  

Cardinal Health, PR         Sterile Manufacturing Facility (CMO)                                        Aug 2003 – Jan 2005 Quality Director- 

• Report to VP Quality / Technical Group, USA. Manage QC Operations (3 Managers QC/Microbiology, 3Supervisors, and approximately 30 laboratory analysts)
• Support aseptic manufacturing processes, methods transfer/validation, investigations, process validation
• Review Change Controls, Methods, Specifications, SOP’s, Manufacturing Validation and Qualification protocols/reports
• Review CMC’s section
• Liaison person with external customers and provide direct support to clients and regulatory inspections 
• Reduce cycle time for testing materials by an average of 30% 
• Manage a laboratory FDA inspection without any FDA 483 observations
• Support product transfer (Process Validation and Equipment Qualification)

Schering-Plough, PR    Solid Dosages                                                                                      July 2002 – July 2003

Quality Services Manager

• Subject Matter Expert on GMP (Supporting Consent Decree Remediation)
• Manage Methods Transfer, Stability Program, Lab Documentation, Investigations, Instrumentation, Supplies and LIMS groups (3 supervisors, and approximately 15 analysts)
• Provide technical support to manufacturing process, method transfer and method validation for 2 new products
• Reduce the evaluation and approval of Change Controls requests, Methods, Specifications, SOP’s, Validation and Qualification protocols from an average of 10 days to 4 days
• Revamp the Laboratory Investigation, Instrument calibration, and analyst qualification programs
• Perform audit and remediation for an FDA Pre-approval Inspection
• Conduct / review investigations / CAPA’s
• Manage a laboratory FDA inspection with zero FDA 483 observations

Searle & Company, PR                                                                                                                

Quality Director                                                                                                                     Dec 1997 – July 2002

• Manage laboratory operations (finished products, raw materials, stability chemical testing, micro testing and incoming activities), quality control, technical services, laboratory instrument CAL/PM program, stability program and Laboratory Information Management System (LIMS). Direct 12 supervisors and 108 professionals, operations and administrative personnel)
• Manage two laboratories FDA/EMA/ANVISA inspections with zero regulatory observations 
• Enforce full regulatory compliance that resulted in two successful pre-approval inspections and launch of two products within four months according Company expectations
• Implement a consignment agreement for laboratory supplies resulting in savings of $80K per year
• The testing cycle time was reduced from 7 days to a maximum of three days (cost saving of approximately $150K)
• Implement a reduced testing program for raw materials and two finished products (cost saving approximately $200K)
• Manage the reduction of budget for instrumentation by $100K, reducing the calibration outsourcing services
• Support/review annual product reviews
• Restructure the laboratory operations resulting in increase of efficiency of 15% while maintaining the laboratory headcount and absorbing an increase of about 20% of volume
• Quality Project Manager for Celecoxib (New Product)

Compliance Improver                                                                                                                      Aug 1997- Dec 1997

• Perform method troubleshooting, method optimization, investigations and laboratory audits.
• Conduct investigations
• Evaluate change controls, process validation protocols, technical documents
• Participate of plant Quality audits

Zenith Laboratories, PR             Quality Assurance Manager                                                    Aug 1994 – Aug 1997                                                                     

Direct Stability, Technical Services and Quality Assurance Teams

• Provide support and troubleshooting to manufacturing of solid dosages (process and cleaning validation)
• Manage methods development, transfer, optimization, laboratory calibration, and Complaint and Change Control programs
• Restructure the Quality Assurance operations to improve the efficiency and to absorb higher volumes.  Resulted in reduction of head counts and reduction of cycle time of disposition of finished products by approximately 30%
• Direct one FDA inspection with zero FDA 483 observations

Quality Control & Technical Services Manager                                                                            June 1993 – Aug 1994                                                                                     

• Review /write CMC section
• Revamp program for method validation and method transfer
• Implement an analyst qualification program
• Conduct investigations and CAPA’s
• Write/review Process Validation /Equipment Qualification Protocols and Reports
• Bring the laboratory into total compliance (Two successful FDA Inspections with zero FDA 483 observations)
• Provide direct support to product transfer (process and cleaning validation)

Anaquest Caribe, PR                    API Manufacturing                                                                    Feb 1989 – June 1993

Quality Director 

• Responsible of Quality Control/Quality Assurance and Technical Services.
• Develop, implemented and evaluated specifications, testing methods and procedures for the site
• Validate/optimize analytical methods and performed methods’ transfer
• Manage the bulk plant process and cleaning validation and product transfer project
• Manage two (2) FDA inspections with zero FDA 483 observations

Interamerican University – San Germán and Río Piedras, PR Campuses                                   Aug 1997 – May 1998 

Part Time Professor                                                                                                                            Aug 2009 – May 2002

• General Chemistry and Organic Chemistry 

Turabo University – Part Time Professor                                                                                         Aug 2010- May 2011

• Chemistry, Aseptic Processing, Team Building and Communication, Quality Systems, Solid Dosages and Industrial Chemistry 

Education:

• Emory University – Atlanta, Georgia (one year)

Post-doctoral work in Organic Chemistry (2 publications)

• University of Wuerzburg – West Germany (3.5 years)

Doctoral Degree in Organic Chemistry (14 publications)

• University Of Puerto Rico – Río Piedras campus (7 years)

Bachelor and master’s degree in Organic Chemistry

Training and Seminars

Memberships, licenses and other professional experiences

• American Chemical Society                         -  American Association of Pharmaceutical Scientists
• Puerto Rico Chemist Association     -  American Association for Quality Control