Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Swathi Vadlamudi

Austin,US

Summary

Quality Assurance Specialist with over 6 years of experience in sterile injectable pharmaceutical manufacturing. Well-versed in current Good Manufacturing Practices (cGMP) and global regulatory standards, including the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Therapeutic Goods Administration (TGA), and Brazilian Health Regulatory Agency (ANVISA). Skilled in managing Deviations, Out of Specification (OOS), Out of Trend (OOT), and Laboratory Incident Report (LIR), with expertise in Corrective and Preventive Action (CAPA) implementation and regulatory audit support. Proficient in Quality Management Systems (QMS) such as TrackWise, with strong knowledge of 21 Code of Federal Regulations (CFR) Part 11, ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).

Overview

6
6
years of professional experience
1
1
Certification

Work History

Quality Assurance Executive

Gland Pharma Limited
04.2022 - 04.2024
  • Led comprehensive investigations for Laboratory Incident Reports (LIRs), Out of Specification (OOS), Out of Trend (OOT) results, deviations, calibration failures, and customer complaints to identify root causes and implement effective corrective actions.
  • Oversaw and maintained Quality Management System (QMS) records including deviations, change controls, and CAPAs utilizing TrackWise to ensure timely closure and regulatory compliance.
  • Performed detailed risk assessments and data trending analyses to support quality improvement and proactive issue resolution initiatives.
  • Collaborated cross-functionally with manufacturing, QC, and IT teams to drive QMS digital transformation projects in alignment with current Good Manufacturing Practices (cGMP).
  • Played a pivotal role in preparing for and responding to USFDA and European regulatory audits, contributing to successful inspection outcomes.
  • Reviewed analytical test data, evaluated stability study results, and conducted audit trail reviews to ensure compliance with data integrity and regulatory standards.

Quality Assurance Senior Executive

Gland Pharma Limited
04.2021 - 04.2022
  • Conducted thorough investigations Laboratory Incident Reports (LIRs), Deviations and Out of Trend (OOT) results, while mentoring team members on effective root cause analysis and compliant documentation practices.
  • Reviewed Annual Product Reviews (APRs) to identify recurring quality trends and drive continuous improvement initiatives.
  • Approved Certificates of Analysis (CoAs), Standard Operating Procedures (SOPs), Corrective and Preventive Actions (CAPAs), and change control records within the TrackWise Quality Management System.
  • Supported internal and external audit activities, ensuring timely implementation and closure of CAPAs in alignment with regulatory expectations.
  • Oversaw document control and archival processes to maintain data integrity and ensure compliance with Good Documentation Practices (GDP).

Quality Assurance Junior Executive

Gland Pharma Limited
04.2019 - 04.2021
  • Managed Laboratory Incident Reports (LIRs) and Out of Trend (OOT) by supporting thorough documentation, follow-ups, and resolution tracking.
  • Contributed to Computer System Validation (CSV) activities, including the execution and documentation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Reviewed Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs), product specifications, and validation protocols to ensure regulatory and procedural accuracy.
  • Verified analytical data for accuracy and compliance, and performed audit trail reviews to support data integrity initiatives.
  • Evaluated analyst qualifications and ensured adherence to Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).

Quality Assurance Officer

Gland Pharma Limited
04.2018 - 04.2019
  • Supported Laboratory Incident Report (LIR) investigations by ensuring accurate, complete, and compliant documentation throughout the resolution process.
  • Reviewed Certificates of Analysis (CoAs), product specifications, and Standard Operating Procedures (SOPs) to verify alignment with regulatory and quality standards.
  • Participated in equipment qualification and validation activities, including documentation and review of protocols and reports.
  • Managed the lifecycle of samples related to materials testing and stability studies, ensuring proper handling, tracking, and documentation.
  • Maintained strict control and archival of laboratory records in accordance with SOPs and Good Documentation Practices (GDP).

Education

Master of Pharmacy (M.Pharm) - Quality Assurance

Sir C.R. Reddy College of Pharmaceutical Sciences
05-2018

Bachelor of Pharmacy (B.Pharm) -

Sir C.R. Reddy College of Pharmaceutical Sciences
05-2016

Skills

  • Quality Management System (QMS)
  • CAPA & Deviation Management
  • Change Control & Document Review
  • GMP Compliance (USFDA, EMA, MHRA, TGA)
  • 21 CFR Part 11 & ALCOA and Compliance
  • Audit Preparation & Regulatory Inspection Support
  • Root Cause Analysis & Risk Assessment
  • Annual Product Review (APR)
  • TrackWise QMS Software
  • Training & Records Management
  • Microsoft Office

Certification

  • Good Manufacturing Practices (GMP)

Timeline

Quality Assurance Executive

Gland Pharma Limited
04.2022 - 04.2024

Quality Assurance Senior Executive

Gland Pharma Limited
04.2021 - 04.2022

Quality Assurance Junior Executive

Gland Pharma Limited
04.2019 - 04.2021

Quality Assurance Officer

Gland Pharma Limited
04.2018 - 04.2019

Master of Pharmacy (M.Pharm) - Quality Assurance

Sir C.R. Reddy College of Pharmaceutical Sciences

Bachelor of Pharmacy (B.Pharm) -

Sir C.R. Reddy College of Pharmaceutical Sciences

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