QA Controlled Documents Coordinator
Location: Bangalore,Mumbai
Category: Regulatory/Compliance
Job ID: 25675
Company: Fortrea
Company Overview
Fortrea is a leading global contract research organization (CRO) providing clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in ~100 countries, Fortrea is transforming drug and device development to improve patient outcomes worldwide.
Role Overview
The QA Controlled Documents Coordinator is responsible for managing, maintaining, and ensuring compliance with controlled documents within Fortrea’s Quality Management System (QMS). This role ensures the availability, accuracy, and regulatory compliance of controlled documents, supporting quality assurance and regulatory teams.
Key Responsibilities
Document Management & Compliance
Administer and maintain controlled documents, ensuring availability to end users.
Follow departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Maintain inventory of controlled documents and ensure timely updates.
Perform quality checks to ensure accuracy and compliance.
Ensure regulatory compliance and adherence to Quality Assurance (QA) procedures.
Process Improvement & Issue Resolution
Complete day-to-day tasks efficiently while maintaining high quality standards.
Ensure timely escalation of document-related issues.
Assist in issue resolution impacting controlled document release.
Training & Collaboration
Complete required training within assigned timelines.
Work collaboratively with internal teams to support document control processes.
Support cross-functional teams in achieving regulatory compliance goals.
Required Qualifications & Experience
Education:
Bachelor’s degree required (or relevant equivalent experience).
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience:
Less than 1 year of experience in document control, quality assurance, or regulatory compliance.
Skills & Competencies:
Strong organizational and communication skills.
High attention to detail and accuracy.
Ability to work independently and within a team.
Proficiency in computer and departmental tools for document management.
Work Environment & Physical Demands
Office-based role requiring extended hours in front of a computer.
About Fortrea
Fortrea is committed to advancing clinical trials and regulatory compliance through innovation and collaboration. We foster a diverse and inclusive work environment, empowering professionals to make a global impact.
Equal Opportunity Employer Statement
Fortrea is an Equal Opportunity Employer (EOE/AA) and does not tolerate discrimination based on race, gender, disability, veteran status, or any other legally protected category.
For more details, visit www.fortrea.com.
If you require accommodations during the hiring process, please contact taaccommodationsrequest@fortrea.com.
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