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Aastha Arora

@aasthaarora2

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Quality review and audit analyst improving pharma compliance, CAPA planning, and pharmacovigilance operations.

India

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What I'm looking for

I’m looking for a role where I can own quality audits and compliance reporting, run root-cause analysis with CAPA support, and strengthen pharmacovigilance/ICSR processes using tools like Argus and MedDRA.

I run quality review and audit work at Evernorth Health Services in Hyderabad, where I check production and audit communications against SOPs and FDA/regulatory requirements using JIRA, Bluerelay, and related portals.

I partner with cross-functional teams to resolve quality gaps, and I lead root-cause analysis on recurring issues to feed corrective action (CAPA) plans and strengthen audit outcomes.

Before that, I worked at GlobalData as an Associate Editor, conducting quality audits on OTC medicine documentation and medical/scientific content, and coordinating corrections with subject matter experts.

Earlier roles covered safety process work in Argus for adverse event case processing, plus OTC quality monitoring and QC data review—always with strong evidence trails and audit-readiness documentation.

Experience

Work history, roles, and key accomplishments

Current

Quality Review and Audit Analyst

Current

Evernorth Health Services

Apr 2024 - Present (2 years 4 months)

Audit communications and production data against SOPs and FDA/regulatory requirements, reducing repeat errors by 63%. Conduct root-cause analysis and contribute to CAPA plans.

Jira BlueRelay Root Cause Analysis CAPA Quality Audits FDA Compliance SOPs

Associate Editor

GlobalData

Aug 2019 - Apr 2024 (4 years 8 months)

Performed quality audits on OTC medicine documentation and scientific content to ensure regulatory compliance. Reviewed and edited pharmaceutical and medical device articles for scientific accuracy.

Quality Audits OTC Scientific Editing Regulatory Compliance SOPs

Assistant Managing Editor

OMICS Publishing Group

Apr 2019 - Aug 2019 (4 months)

Proofread and quality-checked medical journal manuscripts for accuracy and compliance with editorial standards. Coordinated with authors and reviewers to resolve quality issues.

Proofreading Medical Journal Editorial Standards

Senior Executive – Quality (OTC Meds)

Flipkart

Sep 2018 - Jan 2019 (4 months)

Monitored manufacturing and quality control processes for OTC medicines to ensure regulatory compliance. Reviewed production data to identify deviations and support corrective actions.

OTC Quality Control Manufacturing MIS SOPs

Safety Process Associate

VigiMedsafe (PPD)

Mar 2018 - Jun 2018 (3 months)

Processed adverse event case reports in Argus in compliance with pharmacovigilance regulations. Ensured accurate MedDRA coding and narrative quality for regulatory submissions.

Argus MedDRA Pharmacovigilance Regulatory Submissions

Senior Associate

Innodata Isogen

Sep 2016 - Dec 2017 (1 year 3 months)

Performed patent excerption with strict attention to data accuracy and adherence to client quality specifications. Conducted quality checks on extracted patent data.

Patent Excerption Data Quality