Summary
Overview
Work History
Education
Skills
Certification
Additional Information
Technical Tools And Platforms
Timeline
Generic

Swetha Chandraprakash Prajapati

Waterford

Summary

7+ years of global R&D and GMP experience with exposure to combination products and medical devices (prefilled syringes, autoinjectors, inhalers, ophthalmic droppers). Skilled in risk management (FMEA, ISO 14971), CAPA, deviations, change control, and audit readiness. Experienced in electronic quality systems (Trackwise, Veeva), regulatory documentation, complaint handling, and validation support.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Analytical Scientist

Teva Pharmaceuticals
04.2024 - Current
  • Conducted Gemba walks to streamline compliance and operations, reducing sample-prep times by 15% and increasing throughput by 20%.
  • Developed real-time KPI dashboards to track quality system deliverables, including deviation closure metrics and audit readiness, improving visibility of compliance performance.
  • Supported quality and validation documentation related to combination products (e.g., prefilled syringes, autoinjectors, inhalers) in compliance with FDA 21 CFR Part 4 and ISO 13485 requirements.
  • Designed capacity models and productivity strategies to align resources with operational goals.
  • Led global harmonization across three sites as global E&L ambassador and contributor to crossfunctional initiatives.
  • Mentored 40+ researchers in GxP instrumentation, documentation standards, and quality systems.
  • Administered quality systems (deviations, CAPA, change control, audits) in Veeva and Trackwise.
  • Collaborated with IT during software validation activities ensuring compliance with EU Annex 11 and GAMP 5.
  • Supported regulatory ensuring compliance with FDA 21 CFR Parts 210/211 and ISO 13485.

Analytical Researcher

Teva Pharmaceuticals
07.2023 - 04.2024
  • Reduced analysis turnaround by 50% and review time by 75% through template standardization.
  • Supported risk management documentation (ISO 14971 FMEA) and compliance records, contributing to improved deviation and CAPA closure metrics.
  • Authored technical documents for regulatory submissions and internal audits.
  • Created harmonized validation and investigation templates globally, strengthening compliance with ICH Q10 and EU MDR.

Analytical Researcher

Teva Pharmaceuticals
08.2021 - 07.2023
  • Established an R&D lab and supported implementation of electronic quality and documentation systems in compliance with FDA 21 CFR Part 11 and EU Annex 11 requirements.
  • Contributed to FMEA risk assessments (ICH Q9, ISO 14971) and supported deployment of controls that eliminated high-risk deviations.
  • Supported risk management documentation including FMEA, CAPA investigations, and trending metrics in alignment with ISO 14971 and ISO 13485.
  • Administered Trackwise/Veeva workflows (deviations, CAPA, change control, complaints), approved investigations per ICH/FDA.
  • Delivered training on deviation/CAPA workflows and SOP adherence.
  • Participated in regulatory/customer audits, supported facility tours, and contributed to closure of observations.

Research Officer

Encube Ethicals Pvt. Ltd.
02.2021 - 08.2021
  • Supported quality documentation and continuous improvement through root cause analysis aligned with ICH Q10 principles.
  • Assisted in validation of analytical methods for volatile/semi-volatile compounds under GLP & GMP.
  • Authored GLP/ICH-compliant protocols and validation documents.
  • Supported electronic complaint management; tracked corrective action closure metrics.

Analyst

Analytical Solutions (ALS Ltd.)
05.2018 - 02.2021
  • Led process improvements cutting instrument downtime by 20%.
  • Operated and qualified analytical instruments (GC-MS, HPLC, LC-MS) under GLP.
  • Maintained audit-ready documentation supporting quality system compliance (EU Annex 11).
  • Conducted stability and forced-degradation studies; authored technical reports.
  • Supported customer audits, investigated customer complaints, supported E&L testing, and ensured timely compliance with regulatory filings.

Education

Master of Science - Chemistry

University of Mumbai
01.2018

Bachelor of Science - Chemistry

University of Mumbai
01.2016

Skills

  • Risk management
  • Validation/Qualification
  • CAPA
  • Deviations
  • Change Control
  • Audit compliance
  • Complaints
  • Combination Product Compliance
  • Medical Device Compliance
  • Regulatory Compliance
  • SOP/Policy Review
  • Approval
  • Training Delivery
  • Cross-Functional Global Project Collaboration
  • Mentoring
  • Data Analysis
  • Excel Dashboards
  • KPI Reporting
  • LMS
  • Trackwise
  • Veeva
  • MassHunter
  • Chromeleon
  • Empower
  • Agilent
  • Thermo
  • Waters
  • GC-MS
  • HPLC
  • LC-MS
  • Xevo-TQD
  • OpenLab CDS
  • Firstdoc
  • Minitab
  • MS Word
  • Excel
  • PowerPoint

Certification

  • Six Sigma Green Belt
  • Minitab
  • Pivoting Career to Project Management

Additional Information

Contributor to global benchmarking and lessons-learned initiatives, Passionate about mentoring, cross-functional collaboration, and strengthening combination product compliance under FDA 21 CFR Part 4, ISO 13485, and EU MDR

Technical Tools And Platforms

  • Agilent
  • Thermo
  • Waters
  • GC-MS
  • HPLC
  • LC-MS
  • Xevo-TQD
  • MassHunter
  • Chromeleon
  • OpenLab CDS
  • Empower
  • Veeva
  • LMS
  • Trackwise
  • Firstdoc
  • Minitab
  • MS Word
  • Excel
  • PowerPoint

Timeline

Analytical Scientist

Teva Pharmaceuticals
04.2024 - Current

Analytical Researcher

Teva Pharmaceuticals
07.2023 - 04.2024

Analytical Researcher

Teva Pharmaceuticals
08.2021 - 07.2023

Research Officer

Encube Ethicals Pvt. Ltd.
02.2021 - 08.2021

Analyst

Analytical Solutions (ALS Ltd.)
05.2018 - 02.2021

Bachelor of Science - Chemistry

University of Mumbai

Master of Science - Chemistry

University of Mumbai

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Swetha Chandraprakash Prajapati