Naveen Reddy Borancha

Highly motivated and detail-oriented professional with extensive experience in CSV-IT and QACSV for manufacturing equipment. Possessing 5.8 years of expertise in the sterile pharmaceutical industry, brings a deep understanding of industry regulations and quality standards. Known for exceptional communication and interpersonal skills, excels in collaborating with diverse individuals and groups to achieve project objectives.

• QA CSV-IT administrator for Quality oversight and management of Computer System Validation (CSV) in accordance with industry standards and regulatory guidance.
• Author or review testing (IQ, OQ) documentations (protocol & report).
• Having hands of experience in Data back up and restoration of the manufacuting equipments.
• Verified audit trails, ensured logical security, and managed user privileges to maintain robust compliance standards
• Develop and standardize appropriate procedures to be used in validating computerized systems.
• Review proposed changes to validated computerized systems and identify the validation requirements necessary to maintain the system’s validation status after execution of the change.
• Master data creation and verification at all stages of manufacturing and packing operations (Production Units, Equipment types, Equipment’s, and Locations) in eBR and eLOG application along with MES integration.
• Support the Business functions in the periodic review of systems to assess the current validated state.
• Support project teams in the assessment of proposed new computerized systems or software for GxP impact and where GxP impact is identified provide guidance on the risk-based validation approach for the system, working with key stakeholders to achieve business goals.
• Plan the GxP/Initial Risk Assessment & GAMP categorization for new software systems.
• Ensure clients computer systems are appropriately

• QA CSV-IT administrator for Quality oversight and management of Computer System Validation (CSV) in accordance with industry standards and regulatory guidance.
• Author or review testing (IQ, OQ) documentations (protocol & report).
• Having hands of experience in Data back up and restoration of the manufacturing equipments.
• Verified audit trails, ensured logical security, and managed user privileges to maintain robust compliance standards.
• Develop and standardize appropriate procedures to be used in validating computerized systems.
• Review proposed changes to validated computerized systems and identify the validation requirements necessary to maintain the system's validation status after execution of the change.
• Master data creation and verification at all stages of manufacturing and packing operations (Production Units, Equipment types, Equipment's, and Locations) in eBR and eLOG application along with MES integration.
• Support the Business functions in the periodic review of systems to assess the current validated state.
• Support project teams in the assessment of proposed new computerized systems or software for GxP impact and where GxP impact is identified provide guidance on the risk-based validation approach for the system, working with key stakeholders to achieve business goals.
• Plan the GxP/Initial Risk Assessment & GAMP categorization for new software systems.
• Ensure clients computer systems are appropriately validated as per SDLC before release and remain in a compliant state throughout their life cycle.
• Apply risk-based methodologies in the oversight of computer systems and implementation of mitigation plan.
• Upgradation plan for manufacturing legacy equipment to meet regulatory compliance.
• Provide leadership and guidance to Client / Client personnel on CSV matters and ensure compliance to applicable industry regulations.

• Execution of IQ and OQ: Conducted Installation Qualification (IQ) and Operational Qualification (OQ) for a variety of pharmaceutical equipment including Autoclaves, Water Systems, Vial Washing Machines, Vial Depyrogenation Tunnels, Vial Filling Machines, Vial Sealing Machines, Pre-Filled Syringe (PFS) Lines, Vial Labelling Machines, Lyophilizers, Environmental Monitoring Systems (EMS), and Building Management Systems (BMS).
• Conducted Installation Qualification (IQ) and Operational Qualification (OQ) for a variety of pharmaceutical equipment including Compounding vessels and Holding vessels.
• Conducted Installation Operational Qualification (IOQ) for Packing Equipments.

• EBR: Management of electronic batch records
• ELOG: Management of Electronic documentation
• CLEEN: Cleaning validation
• ERP: Management of resources
• EPIC: Training management, Documentation and Quality management systems (CC, PNC, Market complaints, Exception & CAPA).
• Process pad: Establishment of CPP and CQA
• CMS: Management of Calibration
• PMMS: Management of Preventive Maintenance
• HKMS: Housekeeping management
• DSRS: Management of Document Storage & issuance
• ESOP: Management of Electronic SOP Display
• MBMS: Microbial monitoring Management
• WMS: Warehouse management

• USFDA
• WHO
• MHRA
• ANVISA
• MOH
• DCGI
• CSDCO
• Customer Audits
• Global Quality Audits

• FDA, 21 CFR part 11
• WHO TRS
• EU annexures
• PDA
• ISPE
• GAMP5
• ISO

• Name: Naveen reddy Borancha
• Date of Birth: 10/02/97
• Father's Name: Krishna Reddy Borancha
• Languages : Telugu, Hindi, English.
• Address: H.no 8-7/3A JP colony, patancheru, Hyderabad.