Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic

Muzammil Pathan

Pune

Summary

Seasoned validation and quality leader with 10+ years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), and Quality Management within the pharmaceutical domain. Proven expertise in leading global validation programs, ensuring regulatory compliance (21 CFR Part 11, EU Annex 11, GAMP 5), and driving efficiency through risk-based validation, automation, and digital validation platforms (Kneat, ValGenesis, HP ALM, Veeva Vault). Adept at partnering with R&D, Pharmacovigilance, Manufacturing, and IT to deliver compliant, efficient, and scalable solutions. Seeking to leverage validation leadership, regulatory expertise, and strategic execution to drive compliance, efficiency, and innovation in a leading pharmaceutical organization.

Overview

10
10
years of professional experience

Work History

Consultant

ZS Associates
10.2024 - Current
  • Lead validation initiatives for GxP and non-GxP projects across clinical, R&D, and bioinformatics domains.
  • Validation Lead for bioinformatics tools supporting clinical studies; ensured regulatory compliance and audit readiness.
  • Drive CSA adoption by aligning agile practices with GAMP 5, ensuring risk-based validation.
  • Author and review validation deliverables: Validation Plans, Protocols (IQ/OQ/PQ), Traceability Matrices, VSR, error logs, SOP gap analyses.
  • Manage validation lifecycle in Kneat, HP ALM, ValGenesis; provide SME guidance on 21 CFR Part 11, EU Annex 11, GxP controls.
  • Develop go-to-market validation strategies, resource plans, and cost estimations for top pharma clients.
  • Support audits (regulatory & client) and present validation strategy to senior stakeholders.

Project Associate

Cognizant Technology Solutions
12.2021 - 10.2024
  • Led end-to-end CSV activities for a U.S. pharma client in Pharmacovigilance domain, covering Argus, Empirica Signal, Reportum, Spotfire, JReport, etc.
  • Implemented CSA-based Agile validation approach to optimize compliance and reduce documentation overhead.
  • Drafted & reviewed key CSV deliverables: Validation Plans/Reports, URS/FRS, Design Specs, Traceability Matrices, Data Migration strategies, IQ/OQ/UAT test cases.
  • Conducted GxP assessments to classify systems, reported project validation status to senior leadership.
  • Supported global UAT execution & GDP training for business teams.
  • Automated manual tasks with Excel-based macros, improving operational efficiency.
  • Key player in audit readiness & CAPA management.

Sr. Executive

Cipla Pvt. Ltd.
01.2018 - 11.2021
  • Managed CSV activities for R&D systems and change requests.
  • Acted as SME for Electronic Lab Notebook (ELN) – design, validation, CAPA handling, and user support.
  • Validated equipment, instruments, and lab systems (IQ, OQ, PQ); monitored microbiology trends.
  • Guided vendors/support teams on validation; trained users on Good Documentation Practices (GDP).
  • Used HP ALM for validation deliverable lifecycle management.
  • Supported USFDA, MHRA, and internal CSV audits.

Sr. Officer

Lupin Pvt. Ltd.
10.2015 - 01.2018
  • Managed equipment qualification (IQ, OQ, PQ) and validation of lab systems, SCADA, PLC, SAP, and DAS.
  • Handled calibration, requalification, and Excel-based bioassay validations.
  • Active in QAMS (incidents, deviations, CAPA).
  • Successfully supported regulatory inspections (USFDA, MHRA, ANVISA).

Education

M.Sc. - Microbiology

Abeda Inamdar Senior College
01.2015

B.Sc. - Microbiology

Maulana Azad College of Science
01.2013

Diploma - Computer & Information Technology (DCIT)

01.2013

Skills

  • CSV & CSA Strategy Validation Lifecycle Management Regulatory Compliance (21 CFR Part 11, EU Annex 11, GAMP 5)
  • Risk-Based Validation Audit & Inspection Readiness GxP Regulatory Assessments Change Control
  • Digital Validation Tools: Kneat, ValGenesis, HP ALM, Veeva Vault
  • PV & R&D Systems: Argus, Empirica, Reportum, Tibco, Spotfire, Seqera
  • Lab & Manufacturing Systems: SCADA, DAS, GCMS, ELN

Languages

English | Hindi | Marathi | Urdu

Timeline

Consultant

ZS Associates
10.2024 - Current

Project Associate

Cognizant Technology Solutions
12.2021 - 10.2024

Sr. Executive

Cipla Pvt. Ltd.
01.2018 - 11.2021

Sr. Officer

Lupin Pvt. Ltd.
10.2015 - 01.2018

B.Sc. - Microbiology

Maulana Azad College of Science

Diploma - Computer & Information Technology (DCIT)

M.Sc. - Microbiology

Abeda Inamdar Senior College

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Muzammil Pathan