NIDA SAYYED
Hyderabad
Summary
With nearly thirteen years of comprehensive experience in Computer System Validation, I have effectively supported numerous pharmaceutical clients such as Astellas, Eli Lilly, Pfizer, and Novartis. My expertise lies in ensuring compliance with regulatory standards and implementing best practices in validation processes. I possess a strong understanding of GAMP, GxP regulated systems, including SaaS, hybrid cloud and on-premises applications, AI/ML validation, 21 CFR Part 11, and Annex 11 regulations. Proficient in collaborating with cross-functional teams, I deliver solutions that align with clients' strategic objectives. Equipped with strong analytical skills, I consistently drive enhanced efficiency and compliance within validated computer systems.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Senior Consultant
Infosys Limited
09.2021 - Current
- Conduct initial risk assessment and author validation deliverables such as Validation Plan and Validation Report
- Support vendor assessment and review system architecture, requirements specifications, design specifications, functional risk assessments, and code review
- Perform Project Control Maturity Assessment and review retirement plan, impact assessment, and change request
- Validate generative AI application
- Following CSA approach with Agile methodology and review Epic and User Stories
- Demonstrate proficiency in various types of testing including adhoc testing, unscripted testing, regression testing, and performance testing
- Gain expertise in AI/ML testing methods like Hallucinations, Human Evaluation and Adversarial testing
- Utilize skills in applications such as SAP/S4Hana, Clinical Trial, pharmacovigilace and Argus Applications for data migration
- Reviewed Change Request and performed impact assessment
- Assist in security-related activities such as SAST, DAST, and Threat Modeling
- Support the Project Manager in completing compliance activities
- Mentor new joiners to facilitate their professional development
Assistant Consultant
Tata Consultancy Services
07.2019 - 09.2021
- Developed the Author Validation Strategy Document, Verification Protocol, Requirement Specifications, and Business Process Master Listing.
- Conducted Periodic Reviews for GxP and SOX applications.
- Led the validation and verification of BIM level 1 and 2, contributing to a 15% increase in overall process efficiency.
- Reviewed user stories and formulated comprehensive test scenarios for effective testing.
- Facilitated seamless testing by creating and preparing data setup and test setup in ALM.
- Assisted business teams during UAT, ensuring smooth application validation.
- Authored Solution Change Document (Release Plan)
- Reviewed Change Request and performed impact assessment.
- Proactively identified application bugs in the Sandbox environment, achieving a 20% reduction in post-release defects.
- Actively participated in daily stakeholder meetings, ensuring efficient communication between onsite and offshore teams.
- Prepared and delivered weekly project status reports, ensuring stakeholders were informed and aligned.
- Drove process improvement initiatives, resulting in a 10% increase in team productivity.
IT Analyst C2
Tata Consultancy Services(TCS)
01.2013 - 06.2019
- Developed Risk Assessments and validated Plans and Reports for ensuring compliance.
- Authored Release Plans and Notes to facilitate smooth product deployments.
- Conducted Periodic Reviews of GxP and SOX applications
- Prepared Security Plans and Administration SOPs to maintain data integrity.
- Oversaw Corrective and Preventive Action (CAPA) and Deviation management processes.
- Coordinated effectively with clients to address project requirements and feedback.
- Facilitated Onsite-Offshore Communication to ensure seamless collaboration.
- Generated Monthly Status Reports to track and communicate project progress.
- Lead a team of 10 members to achieve project deliverables and milestones.
System Engineer
Tata Consultancy Services
07.2012 - 12.2012
- Developed and implemented migration and validation scripts to streamline processes
- Contributed to system documentation to ensure comprehensive records of processes and procedures
- Provided support for Trackwise system to facilitate smooth operations
- Authored and executed OQ and PQ test cases to ensure system functionality
- Played a key role in change management and incident management to maintain system stability
Assistant System Engineer Trainee
Tata Consultancy Services
03.2012 - 06.2012
- Developed a Sales Ordering System using Java, JSP, Java Script, and CSS
- Created Data Flow Diagram, SRS design, and Entity Relationship Diagram
- Contributed to code writing and implementation in the project
Education
MCA - Computers
Mahatma Jyotiba Phule Rohilkhand University (MJPRS)
01.2011
B.Sc - Maths
Mahatma Jyotiba Phule Rohilkhand University (MJPRS)
01.2007
Skills
- Computer Software Assurance
- Artificial Intelligence Validation
- Computer System Validation
- Team Leading
- Manual Testing
- Agile Testing
- Data Migration
- Impact Assessment
- Compliance Assurance
- Agile Methodology
- Scrum
- Periodic Review
- Access Roster Review
- Risk Assessment
- Critical Thinking
- Vendor Management
Certification
- Professional Scrum Master
- Safe POPM
- J2EE From CMC Delhi
- ISTQB Foundation Level
- ISTQB Foundation Level Agile Tester
- Azure 900
Languages
English
Hindi
Additional Information
I am in Platinum group since last two years in Infosys. Platinum group is one where top 5% candidates come.
Timeline
Senior Consultant
Infosys Limited
09.2021 - Current
Assistant Consultant
Tata Consultancy Services
07.2019 - 09.2021
IT Analyst C2
Tata Consultancy Services(TCS)
01.2013 - 06.2019
System Engineer
Tata Consultancy Services
07.2012 - 12.2012
Assistant System Engineer Trainee
Tata Consultancy Services
03.2012 - 06.2012
MCA - Computers
Mahatma Jyotiba Phule Rohilkhand University (MJPRS)
B.Sc - Maths
Mahatma Jyotiba Phule Rohilkhand University (MJPRS)