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Samirali Meman
@samiralimemon
CSV, IT Compliance , ITQA
India
Inglés, Hindi, Gujarati
Sobre mí
I am a detail‑oriented and proactive professional with 8 years of experience in the pharmaceutical industry, specializing in Data Integrity and IT Compliance. I focus on maintaining data accuracy, system reliability, and regulatory compliance across critical processes. With strong analytical and organizational skills, I help businesses strengthen audit readiness, documentation quality, and overall compliance. If you need precise, reliable, and compliant work.
I’m here to support your project.
Habilidades
Samirali Meman
desconectado •
Tiempo medio de respuesta: 3 horas
Revisa mis servicios
Datos
I will perform computer system validation CSV as per gamp 5 and 21 cfr part 11
Programación y tecnología
I will build custom excel macros vba to automate your workflow
Experiencia laboral
IT Quality _ Corporate IT
Wockhardt Ltd • Tiempo completo
Dec 2025 - Present • 8 mos
To work along with User, IT, QA and Business Project Manager in defining technical controls & compliance requirements to the computerized systems to prevent Data Integrity breaches. Preparation and review of the Computer system validation deliverable (i.e. URS, VP, FS, FRA, IQ, OQ, RTM, VSR). To ensure technical controls are effectively implemented across Manufacturing & Quality IT applications. To ensure ‘Audit Trail and Electronic data’ review of IT systems through ‘Review by exception’ rule to enhance overall compliance on generated & reported data. To perform Periodic review of computerized system. To impart training in Computerized System Compliance with respect to 21 CFR Part 11. Review and drive Change control, CAPA, Deviation, Investigations activities, SOP. To perform internal quality audits of Laboratory, Manufacturing GxP Computerized Systems & ensure closure of audit response with CAPA. Perform Data Governance – Data Integrity Risk Assessment (DG-DIRA) of Enterprise Applications & Computerized Systems.
IT Audit & Compliance (Quality Assurance)
Intas Pharmaceuticals Ltd • Tiempo completo
Aug 2023 - Dec 2025 • 2 yrs 4 mos
To work along with User, IT, QA and Business Project Manager in defining technical controls & compliance requirements to the computerized systems to prevent Data Integrity breaches. Preparation and review of the Computer system validation deliverable (i.e. URS, VP, FS, FRA, IQ, OQ, RTM, VSR). To ensure technical controls are effectively implemented across Manufacturing & Quality IT applications. To ensure ‘Audit Trail and Electronic data’ review of IT systems through ‘Review by exception’ rule to enhance overall compliance on generated & reported data. To perform Periodic review of computerized system. To impart training in Computerized System Compliance with respect to 21 CFR Part 11. Review and drive Change control, CAPA, Deviation, Investigations activities, SOP. To perform internal quality audits of Laboratory, Manufacturing GxP Computerized Systems & ensure closure of audit response with CAPA. Perform Data Governance – Data Integrity Risk Assessment (DG-DIRA) of Enterprise Applications & Computerized Systems.
QC_IT(CSV)
Ajanta Pharma Ltd • Tiempo completo
Mar 2022 - Aug 2023 • 1 yr 5 mos
Preparation and review of the Computer system validation deliverable (i.e. URS, VP, FS, FRA, IQ, OQ, RTM, VSR). To ensure technical controls are effectively implemented across Quality IT applications. To ensure ‘Audit Trail and Electronic data’ review of IT systems through ‘Review by exception’ rule to enhance overall compliance on generated & reported data. Review and drive Change control, CAPA, Deviation, Investigations activities, SOP.
