Post Job Free

Resume

Sign in

Lean Six Pr

Location:
Raleigh, NC, 27616
Posted:
April 30, 2021

Contact this candidate

Resume:

Rafael A. Vázquez

**** ********* ***, *******, ** 27616

e-mail: adl2kb@r.postjobfree.com Phone 919-***-****

PROFILE

Established leader in Validation and Technology Transfers with over twenty (20) years of experience in the Pharmaceutical and Biotech Industry with knowledge of cGMPs, FDA, EMEA, and ISO regulations. Lean Six Sigma Green Belt with ample strengths in Quality Assurance, Regulatory Compliance, Project Management, Process Validation, Equipment Qualification, Troubleshooting, and CAPA’s. Knowledge and application of quality audits skills such as FMEA, RCA and Risk Assessments, among others. Direct participation with FDA, EMEA and ANVISA site audits. Collaboration with cross-functional teams encompassing R&D, QA, Operations and Suppliers, to implement World Class Manufacturing Techniques such as Continuous Improvement (CI) and Lean Six Sigma, Computer and Statistical Process Control.

PROFESSIONAL EXPERIENCE

10/2019 – Present Guerbet, Raleigh, NC Site Validation Manager

Led and managed the Validation Department (Equipment C&Q, Technology Transfer, and Cleaning and Process Validation) consisting of a staff of 4 Validation Engineers, and 1 Consultant.

Redesigned and implemented a Risk/Science based commissioning, qualification and validation program, enhancing and allowing reduction of project implementation lead times, and mitigating compliance gaps.

08/2018 – 10/2019 Biothermal, LLC Sr. Validation Lead

Provide hands-on consulting and project management support on the commodity washer and sterilizer process optimization activities at Hospira, Inc. Rocky Mount, NC commercial manufacturing facility, including engineering studies protocols development, execution and reporting.

07/2017 – 08/2018 Glenmark Pharmaceuticals, Inc ., Charlotte, NC Sr. Validation Manager

Led and managed the start-up/remediation validation activities of three (3) production areas (OSD, Sterile Injectables and BFS); while coaching and mentoring the day to day Validation and Operations Technology Transfer resources, which includes eight (8) validation direct reports.

Successfully concluded an FDA PAI audit with zero critical or major observations.

02/2015 – 06/2017 Amgen, Inc ., Juncos, PR Sr. QA Validation Manager

Led and managed the Aseptic Processing Validation Team consisting of a staff of 15 Validation Scientists.

Managed and applied extensive technical validation engineering expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of processes, systems or facilities.

Provided technical guidance for the sustainability of the routine aseptic manufacturing operations and hands on validation/technical expertise to the drug product parenteral manufacturing operations with broad knowledge on media fill process simulation studies execution, air flow pattern studies, room design and their associated engineering and process interacting controls.

Lead efforts with manufacturing, process development, utilities, facilities, labs and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.

Successfully concluded multiple regulatory agencies audits with zero critical or major observations.

05/2014 – 02/2015 Biothermal, LLC Sr. Validation Lead

Provide consulting and project management support on the remediation of cleaning optimization activities at Hospira, Inc. Rocky Mount, NC commercial manufacturing facility, including monitoring, collecting, analyzing, and presenting process data, which includes streamlining process steps and procedures.

Developed Validation Strategy, Qualification Protocols, provided qualification execution, and Project Management services for several projects which include VisIV Bags, Vials and Ampules Finishing Lines at Hospira Inc. Rocky Mount, NC, and a Serialization System implemented at Hospira Inc, Visakhapatnam, India facility.

Led and managed the Chemistry Lab Equipment Relocation Project at Hospira, Inc. Rocky Mount, NC, which included Project Management, and Corporate Level Status Reporting.

Led and actively performed computerized systems CSV Gap Assessments at the Rocky Mount site, which encompassed Annex 11 / Part 11, and GAMP; for Manufacturing Equipment, IT Systems and Lab Equipment.

10/2012 – 05/2014 Sandoz, Inc., Wilson, NC MS&T Sr. Validation Expert

Developed, and led the implementation for the Process Validation Continued Process Verification (CPV) program at Wilson’s Sandoz Site; structuring the Product’s Lifecycle based on QbD, Science-Statistical-Risk Based approach, and continuous process performance monitoring.

Provided support on the remediation PPQ, Process Development, CPV, process improvement and optimization activities at commercial manufacturing facilities, including collecting, analyzing, and presenting process data, which included streamlining processing steps and procedures.

Investigation Leader, which included statistical analysis, process/cleaning risk assessment, root cause analysis and investigation reporting. Implementation of corrective and preventive actions (CAPA) for process related incidents.

Led the North America Process Validation alignment team by developing and implementing streamlined validation documentation, statistical/scientific based sampling plans, statistical analysis tools, and a Packaging Validation policies and procedures.

Developed and maintained a collaborative working relationship with internal and external partners.

Led and managed the Packaging Validation Remediation activities, which included Risk Assessment Design, Packaging Validation Strategy for 32 Product Families with 77 Product Strengths on 154 SKU’s, Project Management and Planning.

09/2008 – 10/2012 Noven Pharmaceuticals, Inc., Miami, Fl Validation & Technology Transfer Manager

Led and managed the Validation Department (Equipment C&Q, Cleaning, Technology Transfer, and Process Validation) consisting of a staff of 5 Validation Engineers.

Successfully concluded two (2) FDA, one (1) MHRA, and one (1) ANVISA Audits with zero critical or major observations.

Responsible for all corporate validation activities, including design review, start-up, protocol development and execution of Manufacturing Equipment and Processes (Manufacturing, Cleaning, Tech Transfer).

Redesigned and implemented the commissioning and qualification program, enhancing and allowing reduction of project implementation lead times by 25%.

Member of the process improvement, cost reduction and optimization programs.

Led the equipment, facility, and utilities design and C&Q activities for the startup of new manufacturing facility, which included Technology and Process Transfer from parent company located in Japan.

Key member of the alternate supplier, and change control boards for two (2) Noven sites.

Designed and conducted process scale-up, transfer, improvement and optimization activities at commercial manufacturing facilities, including collecting, analyzing, and presenting process data.

Developed and maintained a collaborative working relationship with internal and external manufacturing partners.

10/2007 – 09/2008 Day & Zimmermann Validation Services (Eli Lilly, Carolina, PR), Validation Project Leader

On-time Process Validation activities including planning, protocol generation and execution of solid dosage manufacturing processes (Tablets and Capsules) of four (4) new product launches

Investigation Leader; data revision and analysis, process risk assessment, root cause analysis and investigation report. Implementation of corrective and preventive actions (CAPA) for process related incidents including raw materials.

02/2007 – 10/2007 Amgen Manufacturing Ltd, Juncos, PR Sr. Validation Scientist

Development of Periodic Monitoring Protocols and Summary Reports for Autoclaves and Integrity Testers

Performed process and cleaning validation of biotech parenteral manufacturing processes (Formulation, Fill & Finish and Media Fills) for existing and new products

09/2004 – 02/2007 Day & Zimmermann Validation Services (Eli Lilly/CEPH, Carolina, PR) Validation Project Leader

QA Review and approval for Qualification/Validation protocols (UR, FR, FQ, IQ, OQ, PQ, Cleaning Validation and Process Validation), Technical Reports, Investigations, and Change Controls

Performed process and cleaning validation activities of solid dosage manufacturing processes, including granulation, mixing and dosing form of tablets and capsules for new and existing products

Managed the Batch Record re-engineering for the implementation of Propack (PMX) EBR system

08/2003 – 09/2004 Day & Zimmermann Validation Services, (Eli Lilly/ Wyeth/Schering Plough, PR) Validation Engineer I

Member of the Quality Assurance investigation team in the QA Incoming Area and Steroids Chemical Plant during consent decree remediation plan

GMP Plan Coordinator (PR02) for the development and on-time implementation of a remediation Quality Plan based on FDA Audit recommendations including raw materials, in-process testing, packaging components and final release testing

Development of Validation Protocols and Summary Reports for the solid dosage manufacturing, packaging and cleaning processes for new and existing products and equipment

06/2001 – 08/2003 Day & Zimmermann Validation Services (Aztrazeneca/Cardinal Health, PR) Validation Engineer III

Key liaison between the company and the client. Primary financial accountability and authority of projects.

Led Process (Aseptic and Non Aseptic), Environmental, Utilities, Cleaning, Sanitization, and Sterilization Validations including development, execution, review, and completion of validation protocols and summary reports for six (6) new product launches

Responsible for the qualification and validation activities of the Technical Operations Laboratory; in addition to Air Handling Units and Product Cold Storage (heat distribution and penetration studies)

10/1998 – 06/2001 Wyeth, Carolina, PR Product Release Support Scientist

Provided Analytical support to development and validation exercises for process, cleaning, equipment, facilities, utilities, computer, technology transfers, alternate active product ingredients (API), excipients and manufacturing processes. Develop and optimize laboratory procedures, write and review SOP, protocols and Technical Reports.

Investigated manufacturing and laboratory process, trends, excursions and implementation corrective actions.

STRENGHTS

Strategic Thinking: Developed and executed validation strategies, as well as Project Management, improving efficiencies while maintaining compliance with quality standards.

Innovation and Creativity: Championed teams to innovate validation workstreams improving efficiency and reducing validation costs by focusing efforts on potential risks to product quality attributes and patient safety.

Results Orientation: Led multidisciplinary teams through adversity to overcome challenges for delivering results under remediation environments and improving processes. Established communication channels with Planning, Operations, QC, and QA teams to achieve results.

Risk Taking and Risk Management: Designed strategy to increase process knowledge and mitigate product quality risks.

Problem Solving: Determined root cause and established adequate CAPAs for high complexity investigations applying problem solving methodologies by identifying facts, changes, and distinctions.

Coaching and Mentoring: Improved overall team performance, focus on quality, and motivation levels.

QUALIFICATIONS

Computer knowledge: MS Office (Excel, Word, Power Point, Project, Visio), Auto Cad, Minitab, Trackwise.

Fully Bilingual - English and Spanish. Excellent written and oral communication skills.

Strong Leadership and Public Relations. Teamwork Abilities.

Knowledge of GMP’s, Quality Systems, FDA and European Agencies Regulations.

Knowledge of Inventory and Information programs, and Statistical Process Control.

TRAININGS AND SEMINARS

Current Good Manufacturing Practices (cGMP’s)

Technical courses in: Validation Concepts & Technics, Documentation and Change Control, PAT, Kepner-Tregoe, Part 11 on Computer-Related System Validation, RCA, Continuous Improvement Leadership (CI)

Basic Concepts in Programmable Logic Controller Programming

Quality Systems for Aseptic Processing

EDUCATION

1998 Bachelor in Science, Major in Chemistry, University of Puerto Rico – Mayagüez Campus

CERTIFICATIONS

2012 Lean 6 Sigma Green Belt

AFFILIATIONS

Colegio de Químicos de Puerto Rico

ISPE Member - ID# 263631

PDA Member



Contact this candidate