Rohit Bajaj

Background

About Rohit Bajaj

17+ years of IT experience in various domains Telecom Life Sciences/Healthcare Educational. Over 13 years of experience in Pharmaceutical Biotech Drug Industry with Software Development Life Cycle 21 CFR Part-11 Validation EU Annex 11 Change Control Management testing and implementation of business applications. • Design and develop the goals policies and procedures of the organization’s privacy programs in accordance with appropriate laws and regulations. • Advising staff on their data protection responsibilities • Monitoring the organisation’s data protection policies and procedures • Advising management on whether DPIAs (data protection impact assessments) are necessary for the application. • Publishes privacy notices and local procedures. • Serving as the point of contact between the organization and its customers. • Serving as a point of contact for individuals on privacy matters. • Reviewed and Validated Computer Systems in compliance with 21 CFR Part 11 and GxP FDA Regulations. • Abundant experience in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries. • Working knowledge of GCP GMP GAMP V guidelines especially in the areas of computer or related systems • Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation VP VSR SOPs Protocol Deviation Risk Assessment Decommission report Periodic Review Report • Experience in reviewing all SDLC documents protocols and SOP's to ensure they meet GxP and FDA regulations • Experience in Developing and reviewing User Requirement Specifications URS Functional Requirements Specification FRS and Requirement Traceability Matrix RTM Documents • Good experience in Gap Analysis and documenting Remediation Plan • Excellent Knowledge and experience in Good Documentation Practices • Demonstrated capability to quickly gain a detailed understanding of a process in order to optimize efficiencies and improve quality.