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Skills

  • Cost-reduction initiatives
  • Test plan development
  • Standard equipment
  • Problem resolution
  • EU regulations compliance
  • Manufacturing process optimization
  • Regulatory compliance
  • Process improvement
  • Project organization
  • Design of Experiments (DOE)

Work Experiences

  • Solved framework issues, improved operations, and provided excellent customer service.
  • Authored and reviewed critical documentation such as IQ, OQ, and PQ protocols, ensuring regulatory requirements were met, contributing to a category audit outcome.
  • Achieved consistent regulatory alignment.
  • Championed the validation strategy for HubSpot.
  • Chaired weekly status meetings to review validation progress for program, leading to a 35% improvement in on-time protocol execution.
  • Had an excellent attendance record and was always on time for work.
  • Achieved results within 6 months.
  • Achieved zero observations.
  • Achieved flawless inspections.
  • Championed the validation strategy for Salesforce by establishing clear testing criteria, enabling the project to meet critical milestones and launching on schedule.

Summaries

  • Accomplished validation expert with a strong background in FDA and ISO regulatory compliance, ensuring flawless audits and enhancing overall product safety.
  • Experienced in collaborating with project quality teams and manufacturing quality control personnel to produce industry-leading Adobe Creative Suite.
  • New testers are trained, work is reviewed, and processes are optimized.
  • Accomplished validation expert.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Senior Validation Engineer with a track record of successfully promoting and implementing quality management systems in the Miscellaneous.
  • Strengths in process improvement and cross-functional collaboration backed up by Miscellaneous training.
  • Applied technical expertise in engineering.
  • Adept in driving innovation in validation processes.
  • Achieved initiative.

Accomplishments

  • Resolved product issue through consumer testing.
  • Researched and applied new regulatory guidance during process validation to reduce potential failures by 15%, leading to greater process assurance.
  • Implemented and documented process changes that resulted in improved efficiencies and saved the company approximately $44,000 annually.
  • Identified performance-enhancing opportunities during the qualification of QuickBooks which increased process robustness and exceeded regulatory expectations.
  • Reduced product validation cycle times by 70% by enhancing test case efficiency and resource management.
  • Successfully optimized and validated packaging systems across 16 manufacturing lines, achieving a 58% reduction in defective units and improved throughput.
  • Collaborated with regulatory and quality teams to ensure full compliance of validation activities with both US and EU regulatory requirements, leading to successful product market launches across 18 regions.
  • Authored and executed Installation Qualification (IQ) protocols for complex process equipment, achieving full compliance with regulatory standards within the projected timeline.
  • Evaluated and optimized manufacturing processes for compliance, cost-effectiveness, and operational efficiency, contributing to a 42% reduction in production costs.
  • Authored comprehensive validation documentation and reports for QuickBooks which were critical in passing 6 regulatory audits with zero findings.

Affiliations

  • European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • Society of Women Engineers
  • International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
  • Association for Supply Chain Management (APICS)
  • National Institute for Pharmaceutical Technology and Education (NIPTE)
  • Project Management Institute
  • TÜV Rheinland Global Quality and Safety Network
  • International Association of Administrative Professionals
  • Good Automated Manufacturing Practices (GAMP) Forum
  • International Organization for Standardization (ISO) Support Groups

Certifications

  • ISO 9001:2015 Lead Auditor Certification 2024
  • Certified Validation Professional (CVP) by the Institute of Validation Technology (IVT)
  • Certified Equipment Qualification Professional (CEQP) Beacon Labs
  • Salesforce
  • Certified ISO 13485 Lead Auditor 2021, Vantage
  • Advanced Statistical Process Control (SPC) Training by Vantage
  • FMEA Practitioner Certification ServiceNow, Summit Group
  • GMP Auditing Certification by standard
  • Certified Pharmaceutical Industry Auditor Cedar Works
  • CompTIA Network+

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