Srinivas Prusty Email & Phone Number

Hyderabad, In

Hyderabad, Telangana, India

• Discharge the additional responsibilities of the Data Privacy Officer (DPO) to ensure the personally identifiable data (PII) are managed in compliance with the applicable data protection rules• Act as the point of contact within the organization for the clients and third-party quality assessors for major quality issues, and provide solutions• Establish and promote the organizational policies and processes for Information Security, Data Privacy, Testing and Validation, Client and Vendor Management, Communication and Escalation Plan, etc.• Oversee compliance with organizational policies and processes, coordination among cross-functional teams in client audit and third-party assessors• Regular updates to the Senior Leadership Team (SLT) about the actionable items, data, and metrics in a corporate format• Development of the processes and standards for Software Development, Secure Coding Practice, Cloud Infrastructure Security, Application Security, DevSecOps, Business Continuity, Disaster Recovery, and Regulatory Training • Team management and engagement with the internal stakeholders at various levels to develop a ‘Quality Culture’ in the organization through regular audits and training• Coordinate and ensure timely delivery of support and services to clients as per agreement and plans• Development of organizational documentation (e.g., templates, slides, handouts, newsletters, whitepapers, blogs)

Hyderabad Area, India

• Planning and conducting the audits of GxP-regulated processes that include auditing SDLC (Agile, DevSecOps), Computerized System Validation, Information Security, Electronic Business Processes, Clinical Database Management, Statistical Programming, Imaging Biomarkers, Data Integrity, Data Privacy, etc. • The primary point of contact for GxP Regulatory Compliance for all computerized systems, review of CSV deliverables to regulatory agencies, review and approval of related Corporate Policies and Standard Operating Procedures (SOPs), auditing of technology vendors • Performing the QA review of the processes and procedures across the organization where technology is involved which includes Information Security, Clinical Trial Management System, Randomization and Trial Supply Management, Medical Imaging, Clinical Data Management• Performing the assessment for Serious Breach of GCP and suggesting appropriate corrective actions and preventative actions for critical issues• Providing day-to-day consultancies to the Business/Operation and audit hosting services for various national and international regulatory inspections and client audits.• Holding training sessions for QA colleagues about various industry updates including data privacy, information security, cloud computing, cyber laws, etc.

Mumbai Area, India

Fully responsible for all the activities related to validation of the enterprise application NuLEAP (New Laboratory Enterprise Application Platform) which computerizes the business processes of Bioequivalence Studies. • Implemented software validation process• Computerized System Validation aligned with GAMP 5• Listed out series of tests regarding compliance with 21 CFR Part 11• Prepared Test Scenarios and Test Cases• Designed, developed and executed IQ and OQ of NuLEAP• Coordinated clients for their URS, FS, DS and SOPs.• Installed and configured NuLEAP application• Member of hosting team for various client auditsProject Description:1. NuLEAP for BE (new Laboratory Enterprise Automation Platform for Bioequivalence): is a Java and Oracle based Client-Server architecture that provides end-to-end automation process for data of Bioequivalence Study. This contains various applications and modules which are logical partitions of the bioequivalence business process. I have performed major tasks like: i. Business Case Analysis ii. Business Scenarios iii. Test Cases iv. Validation Documents (IQ, OQ, PQ)2. NuLEAP Data Logger: is a Java and Oracle based Client-Server architecture that provides compliant usage of 'Agilent 34970A Data Acquisition/Switch Unit' device (commonly referred to as the 'Data Logger') which is used to collect and store readings of various parameters (temperature, voltage, current, resistance, etc.) from respective measurement devices connected to it. I have developed following items: i. Test Cases ii. Validation Protocols (IQ, OQ)3. NuLEAP Legacy Data Loader: is a Java and Oracle based Client-Server architecture that provides compliant usage of legacy volunteer data loading from Excel sheets. I have developed test cases based on various scenarios of volunteer data.4.Watson LIMS: Execution and documentation of IQ & OQ of Watson LIMS for Bioanalytical laboratories.

Ahmedabad Area, India

Towards seting-up a new business unit for Computerized System Validation services, I was in-charge of project management, coordination and execution of various projects for number of clients in India. Broadly these projects were IT Infrastructure qualification and validation of laboratory software. Project Description:Third-Party validation/qualification of Desktops, Servers, LAN, Enterprise Applications, Laboratory Software and Data Archivings as per GAMP 4.Activities:• Developed validation documents related to LAN based on ITIL principles and GAMP 4 methodologies under Computer System Validation, and produced written policies, procedures and technical documentation for the same• Review of client’s documents, existing capabilities and controls, categorize the computer systems as per GAMP 4 and applicable regulations• Performed Gap Analysis and Risk Assessment of computer systems, and submitted Validation Summary Report and Traceability Matrix• Developed Validation Monitoring & Evaluation tools, Implementation of ITIL framework aligned with GAMP 4, 21 CFR Part 11, development of SOPs• Pre-sales activities including technical marketing by presentation, discussion with clients about various aspects of services• Validation project planning including communication, scope, scheduling, and deliverables• Hiring, training, forming and managing team • Development of Validation Master Plan and Qualification Protocols• Training staff about Regulations, Standards, and Compliance activities

Ahmedabad Area, India

Managed number of projects to validate the MM, PP, QM modules of SAP R/3 retrospectively for number of clients in India. The major responsibilities were:• Reviewed client’s current set-up of system controls • Performed Gap Analysis and Risk Assessment for SAP R/3 validation• Provided consultancy to client in LAN compliance and management• Developed and documented client’s URS, FS, SOPs, and IQ, OQ, PQ protocols• Conducted training classes for 21 CFR Part 11,GAMP 4, Compliance Basics Project Description:Third-Party validation of MM, PP, QM modules of SAP R/3 (4.7) retrospectively at various sites of clients.Activities:• Team member of Gap Analysis, Risk Assessment and SOPs• Preparation of URS, FS, SOPs• Execution and documentation of validation activities• Support client in LAN Qualification and Compliance

Ahmedabad Area, India

• Physical verification of IT infrastructure, documentation and ITS environment regarding regulatory compliance• Prepared of URS, FS, SOPs• Execution of validation tests

Kolkata Area, India

Early career includes teaching and training of students as per CBSE syllabus at Jawahar Navodaya Vidyalaya, Sarang, Orissa on contract basis (on behalf of Aces InfoTech). Also took classes of Mathematics, Physics and Chemistry on demand basis.• System Administration• Teach computer science, internet, BASIC programming• Train school teachers and students about internet, computer science, BASIC programming• Troubleshooting and handling minor problems in computer, LAN, printer, and software installation

Post Graduate Diploma In Information Security, Computer And Information Systems Security/Information Assurance

Post Graduate Certificate In Cyber Law, Computer And Information Systems Security/Information Assurance

Post Graduate Certificate In Project Management, Project Management

Certificate In Disaster Management, Crisis/Emergency/Disaster Management

Master In Computer Application, Computer Science

B.Sc (Maths), Physics, Chemistry, Industrial Chemistry

Higher Secondary, Physics, Chemistry, Mathematics

High School