SANDEEP KUMAR THATIKONDA

• Currently working for implementation and computer system validation of software applications (QAMS, DMS and BIMS) across the organization.
• Responsible for preparation of User Requirement Specification (URS) of software application.
• Responsible for Initial Risk Assessment, Supplier Assessment.
• Responsible for review and approval of Functional Specification (FS), Configuration specification Document (CSD), Functional Risk Assessment (FRA).
• Responsible for review and approval of Validation Plan, IQ, OQ and PQ protocols, Test scripts , IQ, OQ and PQ summary reports, Traceability Matrix and Validation Summary Report.
• Responsible for Qualification Activities (IQ, OQ and PQ) and implementation of software application Caliber QAMS for handling of Change Controls, Deviations, CAPA, Market Complaints and Audit Management documents electronically across all sites of organization.
• Responsible for Qualification Activities (IQ, OQ and PQ) and implementation of software application Caliber DMS for handling of SOP’s and documents for issuance across all sites of organization.
• Responsible for Qualification Activities (IQ, OQ and PQ) and implementation of software application Ample Logic BIMS for handling of Batch record documents for issuance across all sites of organization.
• GAP Assessment - As per regulatory guidance, verification of facility for compliance and bridging the gaps in system.
• Audit trail review of QAMS,DMS,NICHELON and BIMS Application.
• Review of Change Controls, Deviations and CAPA related to CSV Activities.
• Review of Backup and Restoration files from software applications as per schedule.
• Periodic Review.
• Review of Data migration & System Retirement.
• Planning and scheduling of Audits across the organization.

• Review of user requirement specification and user acceptance testing for intended software applications
• Review & Perform risk assessments such as initial risk assessments, Functional risk assessments, GAMP categorization, GxP assessment, 21 CFR Part 11 assessment
• Preparation of Validation plan
• Review of all CSV deliverables
• Review of Functional specification and Configurational specification
• Preparation and Review of validation protocols such as IQ, OQ, and PQ and Execution of approved OQ test scripts
• Preparation of traceability matrix and validation summary report
• Ensuring of supplier assessment
• Reviewing Test scripts/Qualification
• Coordinate with the IT team to install software and/or hardware and to implement changes in them when required
• Coordinate the activities of deliverables with cross functional departments like project validation plan, standard operating procedures, Traceability Matrix, project validation summary reports, change control, incident management, corrective and preventive actions to establish/maintain validated systems
• Review of periodic Review Plans
• Reviewing the completed Batch Production and Control Records, Equipment use logs and test reports
• Preparation and maintenance of SOPs
• Ensuring that all the calibrations are done as per schedule and calibrating the equipments
• Issue the line clearance for manufacturing
• Product Quality Review.

● Reviewing the completed Batch Production and Control Records, Equipment use logs and test reports.

● Preparation and maintenance of SOPs.

● Ensuring that all the calibrations are done as per schedule and calibrating the equipments.

● Issue the line clearance for manufacturing.

● Product Quality Review.

• Reviewing the completed Batch Production and Control Records, Equipment use logs and test reports
• Preparation and maintenance of SOPs
• Vendor evaluation and qualification for raw materials
• Preparation of Annual Product Review (APR).

• Process validation of Levetiracetam 1000mg coated tablets at Dr Reddy's Laboratories.