Job Title: Quality Systems Specialist

Reports to: Vice President - Operations

1. JOB Purpose

The Quality Systems Specialist oversees implementing quality management procedures, ensuring efficiency and smooth workflow. Main responsibilities include gathering and analyzing data to identify the strengths and weaknesses of current operations, developing recent strategies to optimize quality procedures, creating new quality assurance methods, maintaining quality records, coordinating the quality operations, and implementing solutions, configure and validate Veeva Quality vault, while enforcing the company's policies and regulations.

2. DUTIES AND RESPONSIBILITIES
- Oversee electronic Quality Management System (Veeva QMS);act as the point-of-contact for QMS technical support; function as key subject matter expert for such quality systems.
- Manage Veeva account requests, creation, and modifications.
- Manage the Veeva QMS state of compliance including change management and validation.
- Perform configuration and validation activities of Veeva Quality Docs




- Drive deviation/CAPA process from initiation, impact analysis, root cause analysis, investigation, CAPA planning, effectiveness track, to closure.
- Perform quality record review, quality trending, generate quality metrics, developtools, and establish KPI for the quality systems.
- Assist with preparation and facilitation of Management Review meetings.
- Assist in the performance of companywide internal & external auditing in accordance with GxP as well as regulatory inspections.
- Evaluate gaps of qualitysystem process and authorquality system documents.
- Review change control requests. Prepare documents for QA department related activities.
- Facilitate Change Control Review Board meetings, including impact assessments, and ensure on time approval and closure of change controls.
- Coordinate training regarding regulatory requirements, quality agreements, and corporate processes using the electronic Learning Managem

📌 Quality Systems Specialist (Hyderabad)
🏢 Ocugen India
📍 Hyderabad