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Shraddha Chandwadkar

Location unknown · 10.0 yrs experience (stated)

Computer System Validation professional with 10+ years of experience in regulated pharmaceutical environments and hands-on leadership of validation activities for GxP software implementations and SaaS deployments. Specialized in risk-based validation (GAMP 5), audit-ready documentation, and independent ownership of validation deliverables from URS to Validation Summary Report. Experienced in remote consulting models and coordination with QA, IT, developers, and global stakeholders across pharmaceutical and life sciences domains. Strong background in 21 CFR Part 11 and EU Annex 11 compliance, data integrity assessments, ERES evaluations, and spreadsheet validation for controlled templates. Proven expertise in quality operations including complaint investigations, CAPA, deviations (TrackWise), and support for USFDA, MHRA, and WHO audits. Experienced in validation of analytical instruments including HPLC, GC, Stability Chamber, XRD, PSA, UV, FTIR, and Colorimeter.

Notes

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The model reported low confidence

projects — the model was unsure about: start_date, end_date (across 4 entries)

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No work experience was found

experience — no employment entries; 4 project(s) carry the work history instead

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Many skills couldn't be matched to the taxonomy

skills — 44 of 46 skills are not in the taxonomy yet (96%) — they are stored and searchable under their own names; see the unresolved-skill queue

Experience

No employment history listed — this resume is organised by project. See Projects below.

Projects

GxP Software Validation & CSV Consulting

QA & CSV Manager

Validation of custom-built and configurable GxP software used by pharmaceutical clients. Independently managed end-to-end CSV lifecycle including preparation and review of Validation Plans, Design Specifications, URS, Risk Assessments, IQ/OQ/PQ protocols, RTM, ERES assessments, and Validation Summary Reports. Supported SaaS-style deployments through remote validation execution and documentation review. Authored and maintained CSV and QMS SOPs aligned with regulatory expectations.

  • Independently prepared and reviewed Validation Plans, Design Specifications, User Requirement Specifications, Risk Assessments, IQ/OQ/PQ protocols, RTM, ERES assessments, and VSRs.
  • Validated custom-built and configurable GxP software used by pharmaceutical clients.
  • Validated analytical instruments including HPLC, GC, Stability Chamber, XRD, PSA, UV, FTIR, and Colorimeter.
  • Handled analytical software validation including LabSolutions, OpenLab CDS, and Tiamo.
  • Performed effective review of test protocols including functional testing, role and privilege verification, and data integrity controls.
  • Supported SaaS-style deployments through remote validation execution and documentation review.
  • Collaborated with software developers, quality teams, and plant management teams.
  • Provided consulting for system implementation, change management, and release activities.
  • Authored and maintained CSV and QMS SOPs aligned with regulatory expectations.
  • Supported internal audits by providing validation evidence and regulatory justifications.
  • Provided on-site training on Computer System Validation.

Environment: GAMP 5, 21 CFR Part 11, EU Annex 11, Custom-Built GxP Software, LabSolutions, OpenLab CDS, Tiamo, HPLC, GC, UV, FTIR, XRD, PSA, Stability Chamber, Colorimeter

Corporate Quality – Complaint Investigations, CAPA & Audit Support

Deputy Manager, Corporate Quality

Managed complaint investigations, CAPA, and deviations using TrackWise in a corporate quality function. Supported regulatory audits by USFDA, MHRA, and WHO. Reviewed CAPA effectiveness and quality metrics. Supported USFDA Field Alert Reports (FARs) and delivered technical training programs across the organization.

  • Handled complaint investigations, CAPA, and deviations in TrackWise.
  • Supported USFDA Field Alert Reports (FARs).
  • Reviewed CAPA effectiveness and quality metrics.
  • Supported USFDA, MHRA, and WHO audits.
  • Delivered technical training programs.

Environment: TrackWise, CAPA, Deviation Management, USFDA/MHRA/WHO Audit Support, Quality Metrics

Quality Control – API & Excipient Analysis

Quality Control Analyst

Performed API and excipient analysis using HPLC, UV, and IR with GMP documentation in a regulated pharmaceutical quality control laboratory environment.

  • Conducted API and excipient analysis using HPLC, UV, and IR instruments.
  • Maintained GMP documentation standards throughout all analytical activities.

Environment: HPLC, UV, IR, GMP Documentation

QA Documentation & GMP Compliance

QA Officer

Provided QA documentation support and GMP compliance oversight in a pharmaceutical formulations manufacturing environment.

  • Managed QA documentation and ensured GMP compliance across manufacturing processes.

Environment: QA Documentation, GMP Compliance

Skills

21 cfr part 11audit readinesscapachange control & impact assessmentcolorimetercomplaint investigationscustom-built gxp softwaredata integrity & eres assessmentdeviation managementdeviationsend-to-end computer system validationeu annex 11ftirfunctional & design specification reviewgamp 5gamp 5 risk-based validation strategygcgmp compliancegmp documentationgmp gxp compliancehplciq oq pq protocol authoringirlabsolutionslmsMicrosoft ExcelMicrosoft Officeopenlab cdspsaqa documentationquality metricsrtmsaas custom-built gxp systemssdlc & v-model documentationsop authoring & maintenancesop structuresspreadsheet validationstability chambertiamotrackwiseursurs templatesuvvalidation planvalidation summary reportxrd

Education

None on file.

Certifications

Computer System Validation Certification
· issued 2023-01-01