♛Pavalur♛ ★R♛
About ♛Pavalur♛ ★R♛
Pavalur is a Senior Validation Specialist with extensive experience in GxP compliance and validation processes, currently working remotely in the United States since 2020. He has a strong background in SAP technologies and has led validation efforts for numerous GxP FDA applications.
Current Role and Responsibilities
Currently serving as a Senior Validation Specialist, the individual has been working remotely in the United States since 2020. The role focuses on compliance with 21 CFR Part 11, Good Automated Manufacturing Practice (GxP), and Veeva systems. Responsibilities include overseeing data migration qualification and disaster recovery qualification processes, ensuring that all validation activities meet regulatory requirements.
Professional Experience
The individual has a diverse professional background in validation and IT analysis within the life sciences sector. Prior positions include working as an IT Validation Business Analyst at Wipro Limited and Cognizant, where responsibilities included managing validation processes for GxP compliance and SAP technologies. Notably, they have led validation efforts for over 100 GxP FDA applications across various platforms, including AWS, SAP, and Veeva.
Education and Expertise
The individual holds a Bachelor's degree in Electronics and Communications from JNTUH College of Engineering Hyderabad. They specialize in GAMP 5 Risk-Based Validation, Functional Risk Assessment, GXP Assessment, and 21 CFR Part 11 Assessment. Their educational background supports their extensive knowledge in ensuring consistency and traceability between user requirements and validation processes.
Technical Skills and Specializations
The individual possesses extensive experience with SAP technologies, including SAP FI/CO, Accounts Payable, Accounts Receivable, and S4 HANA. They have a strong background in deviation management processes and CAPA (Corrective and Preventive Actions). Their technical skills also encompass computer system validation engineering and the creation of validation summary reports.
Previous Positions and Contributions
Before their current role, the individual held several positions at Wipro Limited and Cognizant, contributing to various IT validation and compliance projects. They worked on GxP CSV for clinical drug safety and played a key role in validation activities for SAP and Veeva systems. Their experience includes leading validation efforts for critical applications in the life sciences industry.