Summary
Overview
Work History
Education
Skills
Timeline
Generic

Narasimha Mallampati

Elkhart

Summary

Dynamic quality assurance professional with extensive experience at [Previous Employer]. Expert in equipment qualification and CAPA management, driving compliance with FDA regulations. Proven track record in process validation and risk assessment, fostering teamwork and collaboration to enhance operational efficiency. Committed to continuous improvement and maintaining data integrity in all projects.

Overview

3
3
years of professional experience

Work History

Senior Validation Engineer

Roman Pharma
01.2023 - Current
  • Conduct validation testing to ensure product compliance with industry standards.
  • Collaborate with engineering teams to identify and resolve validation issues.
  • Analyzed pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
  • Streamlined equipment qualification procedures for increased efficiency and reduced downtime.
  • Reduced overall project timelines through effective coordination of resources and efficient execution of validation activities.

Education

Bachelor of Science - Pharmaceutical Sciences

Aacharya Nagarjuna University
Andhra Pradesh
04-2017

Skills

  • Equipment qualification
  • CAPA management
  • Testing protocols
  • Quality management systems
  • Validation protocols
  • Data integrity
  • Regulatory guidelines
  • Process validation
  • Test method validation
  • FDA regulations
  • Change control
  • Design control
  • Equipment calibration
  • Measurements and analysis
  • Computer system validation
  • ISO standards
  • Maintenance of engineering systems
  • Record keeping
  • Process analysis
  • Validation master plans
  • GMP compliance
  • Evaluation of engineering systems
  • Critical thinking
  • Regulatory compliance
  • Report writing
  • Change control management
  • Audit processes
  • Validation standards
  • Data integrity validation
  • Teamwork
  • Teamwork and collaboration
  • Problem-solving
  • Attention to detail
  • Problem-solving abilities
  • Multitasking
  • Organizational skills
  • Excellent communication
  • Decision-making
  • Good manufacturing practices
  • Interpersonal skills
  • Analytical thinking
  • Risk assessment
  • Quality control
  • Written communication
  • Continuous improvement
  • Quality assurance
  • Troubleshooting
  • Root-cause analysis
  • Protocol development
  • Technical reporting
  • Statistical analysis
  • Corrective action planning
  • Cross-functional team collaboration
  • Computer-aided design
  • Product lifecycle management
  • Process mapping
  • Process engineering
  • Analytical skills
  • Lean manufacturing
  • Product development
  • Six sigma principles
  • Minitab
  • Experience with JIRA
  • GMP compliance expertise

Timeline

Senior Validation Engineer

Roman Pharma
01.2023 - Current

Bachelor of Science - Pharmaceutical Sciences

Aacharya Nagarjuna University
Narasimha Mallampati