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Sirisha Dandu

@sirishadandu

Quality Assurance Analyst at Clario managing TrackWise Digital quality events and CAPAs across clinical and enterprise operations.

United States
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At Clario, I manage and investigate quality events and deviations in TrackWise Digital. I document root-cause investigations, coordinate CAPA implementation, and develop reports and dashboards that improve visibility into quality events.

At CIPLA USA, I handled deviations, CAPAs, and change controls for metered-dose inhaler packaging. I prepared and revised equipment and process SOPs, supported batch packaging records, and used Fishbone and 5 Why tools for root-cause analysis.

At Denison Pharmaceuticals, I supported ENSUR eQMS and document workflows, including change control, audit items, training records, document migration, and validation test scripts. I also drove approximately 300 product complaints to closure and prepared weekly quality KPI reports.

Earlier, as a Document Management Specialist at Denison Pharmaceuticals, I created and approved laboratory and stability documents and generated Crystal Reports in LIMS. I began in quality control and quality assurance as a Quality Support Intern at Hetero Labs Pvt. Ltd., working with GC and HPLC equipment.

Experience

Work history, roles, and key accomplishments

Education

Degrees, certifications, and relevant coursework

FD

FDA

FDA/NIH: Regulatory Do's and Don'ts, Regulatory Affairs

2025 - 2025

Completed FDA/NIH webinar on Regulatory Do's and Don'ts, covering regulatory resources and early engagement programs.

LI

LinkedIn

SharePoint Administration, SharePoint Administration

2025 - 2025

Completed SharePoint Administration training, covering site architecture, user management, and security features.

LI

LinkedIn

Quality Management Foundations, Quality Management

2025 - 2025

Completed Quality Management Foundations training, covering quality frameworks, continuous improvement, and ISO 9001 principles.

LI

LinkedIn

Smartsheet Essential Training, Smartsheet

2025 - 2025

Completed Smartsheet Essential Training, covering sheet creation, sharing, dashboards, and formula creation.

LI

LinkedIn

Root Cause Analysis, Root Cause Analysis

2025 - 2025

Completed Root Cause Analysis eLearning course, covering 5M's, 5Y's, Pareto Analysis, and Fishbone Analysis.

FD

FDA

Electronic Drug Registration and Listing (eDRLS), Regulatory Affairs

2024 - 2024

Completed FDA webinar on Electronic Drug Registration and Listing (eDRLS), covering NDC format and submission requirements.

MO

Montrium

QMS Bootcamp, Quality Management

2024 - 2024

Completed QMS Bootcamp covering QMS building blocks, SOPs, role-based training, and quality events.

Udemy logoUD

Udemy

Certificate Course in Signal Detection and Management in Pharmacovigilance, Pharmacovigilance

2023 - 2023

Completed Certificate Course in Signal Detection and Management in Pharmacovigilance, covering signal detection and assessment.

Udemy logoUD

Udemy

Certificate Course in Pharmacovigilance ICSR Case Processing, Pharmacovigilance

2023 - 2023

Completed Certificate Course in Pharmacovigilance ICSR Case Processing, covering drug safety and case processing.

Northeastern University logoNU

Northeastern University

Master's Degree, Regulatory Affairs for Drugs, Biologics, and Medical Devices

2013 - 2015

Master's Degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, Boston, MA, from 2013 to 2015.

NI

NIH

Protecting Human Research Participants, Research Ethics

2014 - 2014

Completed NIH web-based training on protecting human research participants.

LP

Lalitha College of Pharmacy

Master's Degree, Pharmacy - Pharmacology

2010 - 2012

Master's Degree in Pharmacy with a focus on Pharmacology from Lalitha College of Pharmacy, India, from 2010 to 2012.

SP

SHADAN College of Pharmacy

Bachelor's Degree, Pharmacy

2006 - 2010

Bachelor's Degree in Pharmacy from SHADAN College of Pharmacy, India, from 2006 to 2010.

Tech stack

Software and tools used professionally

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