Shaik Sameer Ahmed

Shaik Sameer Ahmed Email and Phone Number

| Lead-Computer System Validation | IT QA Regulatory Compliance | Validation | CSA | GxP | GAMP5 | 21CFR Part 11| EU Compliance| @ EY
london, greater london, united kingdom
Shaik Sameer Ahmed's Location
Bengaluru, Karnataka, India, India
About Shaik Sameer Ahmed

A goal oriented professional with 12+ years of experience in Computer System Validation.#Power APPs validation#RPA (Robotic Process Automation) validation#SAP-ECC, S4 HANA validation#ISPE-GAMP5- Cat-4 & Cat-5 validation.#SDLC, STLC, Agile, Waterfall Methodologies.#ManufacturingExecutionSystemEnd to End validation of GxP systems.#e-BMR projects hands on to go liveExpertise in failure Investigations, Root Cause Analysis, CAPA, Change Management, Deviations/ Incident Management.Leading the team with continuous trainings and up gradation to meet current regulatory expectations in pharmaceutical sector.Expertise in 21 CFR, DATA INTEGRITY, Business ethics & Compliance. Conferred with “Star Performer” in Quality & Compliance category.

Shaik Sameer Ahmed's Current Company Details
EY

Ey

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| Lead-Computer System Validation | IT QA Regulatory Compliance | Validation | CSA | GxP | GAMP5 | 21CFR Part 11| EU Compliance|
london, greater london, united kingdom
Website:
ey.com
Employees:
296502
Shaik Sameer Ahmed Work Experience Details
  • Ey
    Senior Consultant
    Ey Aug 2023 - Present
    Bengaluru, Karnataka, India
    Perform end to end CSV activities for GxP computerised systems.Maintain compliance with respect to regulatory standards.RPA validations (Robotic Process Automation)Maintain effective QMS system.Well versed with 21 CFR Part 11 compliance , ISPE GAMP5, EU ANNEX 11.
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  • Ntt Data Services
    System Integration Advisor
    Ntt Data Services Nov 2022 - Aug 2023
    Ensure E2E GxP validations with respect to computerised systems.
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  • Syngene International Limited
    Junior Manager
    Syngene International Limited Oct 2020 - Jul 2022
    Bengaluru, Karnataka, India
    Validation of computerised systemsMES (e-BMR) validationChange managementIncident/ Deviation Management.Successfully faced client audits.Gap Analysis / AssessmentRisk AssessmentTraining plant personnel on procedures and policies.
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  • Fresenius Kabi Ind
    Sr Executive-Qa
    Fresenius Kabi Ind Jul 2018 - Sep 2020
    Pune, Maharashtra, India
    Ensure quality management system at site ( Change Management, Deviation Management , Data Integrity)Ensure validation of GxP systems.Maintain compliance with respect to regulatory standards.Successful faced TGA inspection in 2020.Training plant personnel on procedures and policies
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  • Dr. Reddy'S Laboratories
    Quality Assurance Associate
    Dr. Reddy'S Laboratories Sep 2015 - Jun 2018
    Vizag
    Qualification & Validations, QMSComputers system Validation’s MES (e-BMR) end to end validationRecipe reviewMaterial flow controlWorkflow controlPharmasuite application validation Training plant personnel on procedures and policiesSuccessfully faced USFDA audits 2018.Successfully faced KFDA audits in 2017Successfully faced customer Audits in 2015
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  • Dr. Reddy'S Laboratories
    Assistant Manager
    Dr. Reddy'S Laboratories Sep 2015 - Jun 2018
    Visakhapatnam, Andhra Pradesh, India
    Computers system ValidationMES (e-BMR) end to end validation Recipe reviewMaterial flow controlWorkflow controlPharmasuite application modules
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  • Fresenius Kabi
    Officer
    Fresenius Kabi Sep 2013 - Sep 2015
    Kolkata, West Bengal, India
    Manufacturing AssuranceReview of batch recordsReview of Process flow chartsReview of qualification protocols and ReportsReview of QMS documentsReview of validation deliverables.Successfully faced USFDA, MHRA, KFDA audits from 2103 to 2015.
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Shaik Sameer Ahmed Education Details

  • Krishna University, Machhlipattanam
    Krishna University, Machhlipattanam
    A

Frequently Asked Questions about Shaik Sameer Ahmed

What company does Shaik Sameer Ahmed work for?

Shaik Sameer Ahmed works for Ey

What is Shaik Sameer Ahmed's role at the current company?

Shaik Sameer Ahmed's current role is | Lead-Computer System Validation | IT QA Regulatory Compliance | Validation | CSA | GxP | GAMP5 | 21CFR Part 11| EU Compliance|.

What schools did Shaik Sameer Ahmed attend?

Shaik Sameer Ahmed attended Krishna University, Machhlipattanam.

Who are Shaik Sameer Ahmed's colleagues?

Shaik Sameer Ahmed's colleagues are Amith Kallupalam, Tanvi Upadhyay, Fabián Sepúlveda Ávila, Anugraha Sekar, Chunxiao Li, Mayur Gowda, Brenda Firmano.

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