Quality Assurance Professional - GMP Data Integrity & CAPA Expert

SWATI SINGH

San Diego, CA

858-***-**** ****************@*****.***

Authorized to work in the U.S. (H4-EAD)

PROFESSIONAL SUMMARY

Quality Assurance professional with 6+ years of experience in pharmaceutical manufacturing and analytical laboratory environments operating under cGMP and GLP regulations. Strong background in deviation investigation, CAPA management, batch record review, analytical data verification, stability studies, and audit support. Experienced in maintaining Quality Management Systems (QMS), ensuring data integrity (ALCOA+), and supporting inspection readiness. Fully authorized to work in the U.S. and seeking mid-level QA / Quality Systems roles.

CORE COMPETENCIES

cGMP (21 CFR Part 210/211) Compliance

Deviation Investigation & Root Cause Analysis (5-Why, Fishbone)

CAPA Management & Change Control

Batch Record Review & Product Release Support

Stability Studies (ICH Q1A)

Analytical Data Review & Verification

Data Integrity (ALCOA+)

SOP Authoring & Revision

Internal & External Audit Support

Risk Assessment & Quality Metrics Trending

Document Control & Records Management

Environmental Monitoring Oversight

PROFESSIONAL EXPERIENCE

QA Executive

Venus Lab Aug 2016 – Jan 2021

Reviewed and approved analytical test data for raw materials, intermediates, and finished products to ensure compliance with cGMP specifications prior to batch release.

Led deviation investigations and performed root cause analysis using structured methodologies; initiated and tracked CAPA to ensure timely closure and regulatory compliance.

Maintained and supported the Quality Management System (QMS), including document control, periodic review, and training compliance tracking.

Reviewed batch manufacturing records, QC documentation, validation protocols, and calibration records for completeness and compliance.

Ensured equipment calibration and validation activities were current and compliant; reviewed and approved calibration certificates.

Authored, reviewed, and revised SOPs to maintain alignment with regulatory and operational requirements.

Coordinated document change control activities and ensured proper archival of controlled records.

Supported internal audits and external regulatory inspections; maintained inspection readiness.

Reviewed and approved analytical method validation protocols and reports.

Assisted in training staff on QA procedures and documentation practices.

QA Analyst

Analytical Solution Pvt. Ltd. Jan 2013 – Nov 2013

Reviewed and approved analytical methods and validation documentation for finished products.

Prepared and maintained quality documentation including test results, deviation reports, and validation reports in compliance with GLP and cGMP standards.

Managed SOP revisions and implementation to ensure regulatory compliance and procedural accuracy.

Supported internal and external audits and ensured corrective actions were implemented effectively.

Monitored laboratory equipment calibration records and ensured compliance with documentation standards.

Conducted environmental monitoring and ensured laboratory conditions met required specifications.

QC/QA Officer

Anazeal Analytical Pvt. Ltd. Mar 2010 – Dec 2012

Performed analytical testing of raw materials, intermediates, APIs, and finished products in compliance with approved specifications.

Conducted stability studies in accordance with ICH guidelines and documented results for regulatory reporting.

Operated and reviewed analytical instrumentation including HPLC (Waters Empower), UV/Vis spectrophotometer, KF titrator, dissolution apparatus, pH meter, and related equipment.

Prepared Certificates of Analysis (COA) and managed sample reconciliation activities.

Supported deviation documentation and maintained inspection-ready laboratory records.

Assisted with internal and external audit preparation.

EDUCATION

Master of Science (M.Sc.), Analytical Chemistry

Mumbai University

Bachelor of Science (B.Sc.), Chemistry & Biochemistry

Mumbai University

(WES evaluated – U.S. equivalency available upon request)

PROFESSIONAL DEVELOPMENT & CERTIFICATIONS

QA/QC Certification – UC San Diego Extended Studies (Currently Enrolled)

Introduction to Electronic Document Management

Fundamentals of Quality Assurance

PG Diploma in Regulatory Affairs (Formulation), IPM Mumbai

TECHNICAL SKILLS

Analytical Instruments:

HPLC (Isocratic & Gradient – Waters Empower), UV/Vis, KF Titrator, Dissolution Tester, Disintegration Apparatus, pH Meter, Tablet Hardness Tester, Friability Tester

Software:

Microsoft Office (Excel – data trending, reporting; Word; PowerPoint)

PROFESSIONAL NOTE

Relocated to the United States and completed professional development in U.S. regulatory frameworks and quality systems. Fully authorized to work and actively pursuing QA roles within pharmaceutical and life sciences industries.

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