Divya Sharma

Quality Assurance Professional - THEON PHARMACEUTICALS

(2026-01)

Coordination with CSV vendors for software implementation (EDCS) & documentation control and compliance verification.
Manage regulatory inspections and oversee the comprehensive review of audit reports and observations.
Drive the timely closure of audit findings while implementing long term, scalable compliance measures.
Lead corrective and preventive action plans to solve root issues.
Reviewing Process Validation protocols & PV reports to ensure compliance with regulatory and quality requirements.
Preparation and reviewal of hold time study reports in accordance with GMP guidelines.

QA Specialist - ACME CORPORATE OFFICE

(2024-08 - 2025-12)

Responsible for performing the audit trail of QA software {EAPQR, Elog, EDCS, EBRM, ERP, LIMS, LMS} and assigning training to concerned personnel through Learning management System (LMS) software as training coordinator.
Coordinate with vendors to address quality related issues and ensure compliance with GMP standards.
Responsible to initiate QMS activities i.e. CAPA, Deviation and Incident as per assigned task on defined time.
Implement and maintain software systems, ensuring adherence to regulatory requirements and organizational policies.
Responsible for preparing, revising and maintaining SOP's or other QA documents to fulfill regulatory compliance obligations.
Conduct compliance checks and audits to ensure software systems along with qualification and validation protocol (IQ, OQ & PQ) to meet regulatory ethics.
Document software system changes, updates and maintenance activities for compliance purposes.
Collaborate with cross-functional teams to achieve objectives, providing guidance to ensure successful project outcomes.

Quality Assurance Executive - TORRENT PHARMACEUTICALS LTD.

(2023-12 - 2024-08)

Line clearance at different stages of manufacturing and packing stages.
To perform AQL (tablets & capsule at semi-finished and finished stage).
In-process check performed at different stages of manufacturing and packing stages.
To perform sampling at different stage of manufacturing and packing stage.
Review of batch related documents like BMR & BPR.
Exposure to track wise & SAP software.
To review QMS documents such as OOS/OOT (CAPA effectiveness & trend reports) etc.
To assist in APQR reports.
Review of BMR, BPR, and PDR as per stage along with preparation of CPV & CPP.

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