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