Mukul Singh
New Delhi
Summary
Experienced Validation Lead with a comprehensive skill set in computer system validation processes, risk assessment, change management, CAPA services, and document review. Proven ability to independently lead validation projects, ensuring timely delivery and client satisfaction. Proficient in Agile methodologies and well-versed in regulatory requirements, including 21 CFR Part 11, GAMP5, GxP, and FDA guidelines. Additionally, bring expertise in end-to-end validation within the life sciences domain and experience in validating generative AI and machine learning applications.
Overview
4
4
years of professional experience
Work History
Validation Lead
Tata Consultancy Services
10.2020 - Current
- Experienced Validation Lead with comprehensive skill set in computer system validation processes, risk assessment, change management, CAPA services, and document review
- Proven ability to independently lead validation projects, ensuring timely delivery and client satisfaction
- Proficient in Agile methodologies and well-versed in regulatory requirements, including 21 CFR Part 11, GAMP5, GxP and FDA guidelines.
- Expertise in Validating Generative AI/ Machine Learning (ML) Projects.
Education
Bachelor of Technology, Study Program -
GL Bajaj Institute of Technology And Management
08.2020
Skills
- Computer System Validation
- Software Development Lifecycle (SDLC)
- Agile methodology
- Periodic Reviews
- Deviation Management
- Generative AI/ ML Validation
- V-Model
- ALCOA
- Change Management
- CAPA Services
- Data Integrity
- Risk Assessment
- Veeva Vault QualityDocs
- ServiceNow
- Archer
- Jira
- Effective Communication
- Project Management
- Regulatory Compliance (21 CFR Part 11, GAMP5, FDA, GxP)
Accomplishments
Recipient of awards, including "Star of the Month," "Spotlight Awards," and the esteemed "Highest T- Factor Award" for rapid learning.
Languages
English
Hindi
Hobbies and Interests
Passionate about traveling and exploring new places.
Timeline
Validation Lead
Tata Consultancy Services
10.2020 - Current
Bachelor of Technology, Study Program -
GL Bajaj Institute of Technology And Management
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