Pharmaceutical Quality, Remediation, GMP, ISO Standards, and GXP Expert

Technical Consultant #2116

Pharmaceutical industry Good Manufacturing Practices, (GMP) and ISO Standards.
Ability to manage multicultural environments, motivate staff members and implement company objectives.
Diverse manufacturing and compliance activities.
TPS tools, Lean, Six Sigma and Toyota Kata.
Latin America experienced. Bilingual, Spanish and English.

Undisclosed Company, Manufacturing - Quality, 2014 - 2015

Director of Operations and Consulting Services

Responsible for the review and implementation of Quality Improvement and remediation plans identified through GMP audits.
Ensure Policies and Standards Operating Procedures (SOPs) are implemented across sites in accordance with global GMP, GXP and PV guidelines.
Maintain necessary leadership to ensure that new policy deployment and timeline execution is met, across all locations.
Strengthen management practices to increase operational effectiveness and profitability by conducting strategic planning session, developing short and long term goals.
Managed the Supplier Audits Process Validation (PV) program.
Drive quality and compliance mindset by coaching and mentoring new and existing staff members while providing direction and holding staff accountable for obtaining results.
Assured that sites are in a state of inspection readiness, and provide support as needed during internal, external inspections and audits.
Provided assistance with quality initiatives, project plan development and implementation.
Provided direction and hold staff accountable for obtaining results.

Banner Caps, Division of Pantheon Pharmaceutical, Mexico City, Mexico, 2014

Lead Compliance Consultant

Guided company to gain entrance into the U.S. market by establishing compliance requirements with 21 CFR 211 and 21 CFR 111.
Managed a large multi-discipline group of Consultants tasked with updating and developing quality system documentation in support of 21 CFR 211 and 21 CFR 111.
Ensure that all criteria for release have been met including the acceptance of all exception documents (Deviations; Non-Conformance Reports (NCR's); Out-of-Specification (OOS) Reports) and reconciliation of product.
Reviewed and approved all deviations and CAPA plans. Performed comprehensive review of existing Process Validation (PV) documents.
Worked with Production and QA/QC staff, demonstrating root cause analysis while investigating non-conformance (NOE).
Assist production and QC to resolve technical issues and write the necessary investigations.
Acted as Quality Liaison between Manufacturing sites and Quality organization for all GMP initiatives.
Maintained constant communication with top leadership, kept record of all work performed and report progress, weekly.

Merck Pharmaceutical, Miami Lakes, FL, Senior Consultant-Process Improvement, 2013 - 2013

Responsible for the support and deployment of Hoshin Kanri methodology and Toyota Kata process improvement tools.
Successfully performed in three key areas of the Toyota Kata process: Learner, 1st Coach and 2nd Coach and effectively transitioned to teach the process to others in the organization.
Supported team members assigned to track progress, expedite production activities and perform in-depth process analysis using TK, Lean and Six Sigma tools.
Successfully coached over 60 sessions of Plan-Do-Check-Act (PDCA) cycles. Delivered progress, quality improvement and financial gains.
Achieved overwhelming success identifying and removing variability from manufacturing and packaging processes, which ultimately led to a 30% improvement in quality performance and 20% improvement in product yields.
Made improvements permanent by implementing standard work and work Instructions as part of the quality system standards.
Tracked efficiency, product yield, and equipment reliability as key matrices to make business decisions and capacity planning.
Provided client with timely, reliable, well-structured information regarding KPI performance and contingency plans for corrective measures.

Beckman-Coulter, Miami, FL, Operations Manager, Engineer, 2006 - 2011

Responsible for process improvement and implementation of Lean Six Sigma methodology.
Assisted TPS Field Experts to developed and deploy Hushin Kanri style of planning and execution while coaching and developing stakeholders in the use of Lean and Six-Sigma tools.
Led numerous initiatives aimed at permanently fixing production issues and supply chain interruptions related to poor work flow and materials mismanagement.
Significantly reduced consumer complaint investigations and CAPA action by developing proper root-cause-analysis to prevent recurrence of same problems.

Schering Plough Pharmaceutical, Miami Lakes FL, 1996 - 2011

Business Operations, Manufacturing, Quality and Supply Chain

Serving as Manager of Operations, responsible for the manufacturing of solid dosage and transdermal products to be consistent with established specifications as to quality, quantity and on time delivery while ensuring that all necessary equipment and facility needed to maintain GMP compliance was accessible and up to date.

Plant Operations Engineer, 2002 - 2006

Responsible for supporting FDA Consent Decree activities and site transformation efforts.

Production Process Lead, 1998 - 2002

Promoted to lead a Cytotoxic Production process at the University of Iowa, Collage of Pharmacy, responsible for Production, Facility Containment, Compliance and Safety. Managed FDA and FMEA regulatory inspections and successfully accomplished drug approval in the U.S. and Europe.

Credentials

Aviation Technology A & P FAA Licensed, Teterboro School of Aeronautics (TSA), Teterboro, NJ

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Awards