Quality Associate Job at Fortrea in Mumbai | Medical Graduates Apply
The Quality Associate Job at Fortrea is an excellent opportunity for professionals seeking growth in pharmacovigilance and quality operations. This full-time role, part of the latest Fortrea jobs lineup, is based in Mumbai and focuses on safety report reviews, regulatory compliance, and global quality processes, making it ideal for experienced candidates looking for impactful jobs in Mumbai.
Job Details:
- Job Title: Functional Quality Associate II
- Location: Mumbai
- Time Type: Full-time
- Job Requisition ID: 256051
About the Company
Fortrea is a global contract research organization delivering clinical development, pharmacovigilance, and regulatory services to biopharmaceutical and medical device companies. Among leading Fortrea jobs, this Quality Associate Job supports global safety operations and regulatory excellence across clinical and post-marketing environments.
Qualifications
Bachelor’s, Master’s, or PhD degree in Medicine or Alternative Medicine, Medical Science, or a related area
Experience Required
- Minimum 2+ years of experience in the pharmaceutical, biotechnology, or CRO industry
- Experience in Pharmacovigilance, Safety Writing, Peer Review, or Quality Review
- Knowledge of medical and drug terminology
- Knowledge of ICH Guidelines, GCP, GVP, EU and FDA regulatory requirements
- In-depth understanding of case processing and assessment
- Technical proficiency in Microsoft Office applications
Job Description
This Quality Associate Job at Fortrea involves functional quality operations associated with products, including adverse event processing, safety data review, and global regulatory submissions, making it one of the most sought-after Fortrea jobs among experienced professionals seeking jobs in Mumbai.
Key Responsibilities
- Perform quality review of safety reports
- Assist in compiling quality metrics and identifying quality trends
- Assist in addressing periodic client quality reviews
- Assist in the preparation of corrective and preventive actions
- Assist in ensuring CAPA results are implemented and documented
- Perform review of safety reports and regulatory documents, including annual reports, PSURs, PADERs, clinical study reports, Core Data Sheets, USPI, SPCs, and MedGuides
- Support functional quality operations related to adverse events processes
- Manage expedited adverse events, product quality complaints, and medical information within agreed timelines
- Assist in training schedule design and training material development
- Participate in discussions on quality errors and process improvements
- Assist in coordinating internal, client, and external audits
- Assist in the development of Quality Management Plans
- Support regulatory inspections at client or sponsor sites
- Analyze data and suggest strategies for process improvement
- Execute drug safety data management processes, including call intake review and case follow-up
- Guide safety associates in managing voice calls
- Perform additional support activities, including metrics tracking, QC, training, and reconciliation
