Vamshi Pulusu Email & Phone Number | I am Sr Validation and IT systems compliance professional with results-driven Validation and Quality Assurance professional with 10+ years of diverse experience in the Pharmaceutical Industry. Adept in Computer System Validation (CSV) and Computer System Assurance (CSA), Lab, and Manufacturing equipment software validation, ensuring compliance with FDA regulations (21CFR Part 11, Part 50, 56, 58, 210, 211, 312, 314, 820) and EU Annex 11. Specialized in SDLC, Risk based approach CSV, Integrations and IT Compliance projects Proven track record in drafting and executing validation life cycle deliverables, including Risk assessments, VPP, URS, FRS, Vendor assessments, System design specifications, IQ, OQ, PQ, RTM, and Final summary reports. Exceptional skills in managing Quality Management Systems (QMS) deviations, CAPA, change control, and ensuring data integrity (ALCOA+), Cyber security assessment and cloud security assessment. A collaborative team player with proficiency in application development tools like JIRA, ALM, and ServiceNow. AREA OF EXPERTISE : CSV Projects: Proficiently validated Electronic Document Management Systems – Val Genesis, Doc Compliance, Kneat, and Document Review Systems, ensuring rigorous compliance. Validated Asset Management Systems including BMRAM R3SR4, QUMAS Event Handler v1.0, Nautilus LIMS 9.3, Labware LIMS V6, and overseeing Empower2 to Empower3 remediation. Validated QC lab instruments and manufacturing equipment Software Validated in Spreadsheet, Learning Management System (LMS), Delta V, Process Management Control System (PMCS), Unicorn Software, PLC systems, Process Historian, Bioinformatics systems (BFx), and In house built Enterprise systems. Established documentary evidence for the validated data and ensured the accuracy for compliance audits. Regulatory Compliance: In-depth knowledge of 21CFRPart11, ERES, and ALOCA+ for robust data integrity. Proficient in SDLC, V Model, GAMP4, and GAMP5 guidelines, executing system remediation, risk mitigation, and delivering comprehensive Validation documentation including Risk assessments, VPP, URS, FRS, Vendor assessments, System design specifications, IQ, OQ, PQ, RTM, and Cyber security assessment, Cloud security assessment, Periodic reviews and Final summary reports. Skilled in managing Audit trails, Deviations/Defects, and compiling Final Summary Reports.

Vamshi Pulusu

I am Sr Validation and IT systems compliance professional with results-driven Validation and Quality...
Raleigh-Durham-Chapel Hill Area, Raleigh-Durham-Chapel Hill Area, United States

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Vamshi Pulusu’s Email vamshi.pulusu@regeneron.com

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Vamshi Pulusu’s Location Raleigh-Durham-Chapel Hill Area, Raleigh-Durham-Chapel Hill Area, United States

Vamshi Pulusu’s Current Industry Astellas Pharma

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Work Experience

Astellas Pharma

Sr CSV/IT Compliance Consultant

2022-10-01 00:00:00 - Present

Clade Therapeutics

Sr GxP System Compliance Specialist

2023-08-01 00:00:00 - 2024-02-01 00:00:00

Caris Life Sciences

Sr CSV Consultant

2021-09-01 00:00:00 - 2022-10-01 00:00:00

Regenxbio

QA Validation Consultant

2021-10-01 00:00:00 - 2021-12-01 00:00:00

Regeneron

Validation Specialist

2016-03-01 00:00:00 - 2021-09-01 00:00:00

Shire

Validation Engineer

2015-01-01 00:00:00 - 2016-02-01 00:00:00

Dizer

Validation Consultant

2013-09-01 00:00:00 - 2014-12-01 00:00:00

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FAQ About Vamshi Pulusu

Vamshi Pulusu is located at
Raleigh-Durham-Chapel Hill Area, Raleigh-Durham-Chapel Hill Area, United States

Vamshi Pulusu is a I am Sr Validation and IT systems compliance professional with results-driven Validation and Quality Assurance professional with 10+ years of diverse experience in the Pharmaceutical Industry. Adept in Computer System Validation (CSV) and Computer System Assurance (CSA), Lab, and Manufacturing equipment software validation, ensuring compliance with FDA regulations (21CFR Part 11, Part 50, 56, 58, 210, 211, 312, 314, 820) and EU Annex 11. Specialized in SDLC, Risk based approach CSV, Integrations and IT Compliance projects Proven track record in drafting and executing validation life cycle deliverables, including Risk assessments, VPP, URS, FRS, Vendor assessments, System design specifications, IQ, OQ, PQ, RTM, and Final summary reports. Exceptional skills in managing Quality Management Systems (QMS) deviations, CAPA, change control, and ensuring data integrity (ALCOA+), Cyber security assessment and cloud security assessment. A collaborative team player with proficiency in application development tools like JIRA, ALM, and ServiceNow. AREA OF EXPERTISE : CSV Projects: Proficiently validated Electronic Document Management Systems – Val Genesis, Doc Compliance, Kneat, and Document Review Systems, ensuring rigorous compliance. Validated Asset Management Systems including BMRAM R3SR4, QUMAS Event Handler v1.0, Nautilus LIMS 9.3, Labware LIMS V6, and overseeing Empower2 to Empower3 remediation. Validated QC lab instruments and manufacturing equipment Software Validated in Spreadsheet, Learning Management System (LMS), Delta V, Process Management Control System (PMCS), Unicorn Software, PLC systems, Process Historian, Bioinformatics systems (BFx), and In house built Enterprise systems. Established documentary evidence for the validated data and ensured the accuracy for compliance audits. Regulatory Compliance: In-depth knowledge of 21CFRPart11, ERES, and ALOCA+ for robust data integrity. Proficient in SDLC, V Model, GAMP4, and GAMP5 guidelines, executing system remediation, risk mitigation, and delivering comprehensive Validation documentation including Risk assessments, VPP, URS, FRS, Vendor assessments, System design specifications, IQ, OQ, PQ, RTM, and Cyber security assessment, Cloud security assessment, Periodic reviews and Final summary reports. Skilled in managing Audit trails, Deviations/Defects, and compiling Final Summary Reports.

Vamshi Pulusu currently works in the Astellas Pharma |

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Vamshi Pulusu has prior
experience in the following industries:
Clade Therapeutics | Caris Life Sciences | Regenxbio | Regeneron | Shire | Dizer

Vamshi Pulusu has the following professional experience:
Astellas Pharma | Clade Therapeutics | Caris Life Sciences | Regenxbio | Regeneron | Shire | Dizer