Functional Quality Associate Job At Fortrea
Fortrea is hiring a Functional Quality Associate II in Mumbai to support quality review, pharmacovigilance, and regulatory compliance operations. This role ensures high-quality service for clients while assisting in CAPA implementation, audit coordination, and safety data management in a pharmaceutical and clinical research environment. Graduates seeking Pharmaceutical Science Jobs or Pharmacy Jobs can apply now.
Job Details
- Job Title: Functional Quality Associate II
- Location: Mumbai – Full-Time
About the Company
Fortrea is a global leader in pharmaceutical and clinical research services, providing high-quality solutions to clients worldwide. The company fosters a collaborative, innovative, and growth-oriented environment where employees are empowered to contribute to quality excellence and regulatory compliance.
Educational Requirements
-
Bachelor’s, Master’s, or PhD in Pharmaceutical Science
Key Responsibilities
- Perform quality review of safety reports and related documentation
- Compile quality metrics and identify trends for reporting
- Assist with client quality reviews and CAPA implementation
- Ensure proper documentation of CAPA results in coordination with project managers
- Review safety reports, regulatory submissions, and labelling documents for global clients (annual reports, PSURs, PADERs, clinical study reports, Core Data Sheets, USPI, SPCs, MedGuides, etc.)
- Support adverse events management and pharmacovigilance processes for clinical and post-marketing products
- Manage expedited adverse events, product quality complaints, and medical information queries
- Assist in process compliance review, training schedules, and quality management plan development
- Coordinate client audits and regulatory inspections with Quality Lead/Manager support
- Analyze data to suggest process improvements and quality excellence strategies
- Respond to medical information queries and quality complaints via calls, emails, and faxes
- Guide and support junior safety associates in call management and documentation
- Perform QC of process steps and track information metrics
Skills Required
- Knowledge of pharmacovigilance, GCP, and GVP regulations
- Understanding of ICH guidelines, FDA, and EU regulatory requirements
- Case processing, assessment, and peer review experience
- Ability to generate and analyze quality metrics, CAPA reports, and trend analysis
- Strong knowledge of medical and drug terminology
- Proficiency in the Microsoft Office suite
- Coordination and communication skills across cross-functional teams
Why This Job Role?
This role provides an opportunity to work in a global pharmaceutical services environment with exposure to pharmacovigilance, quality review, and regulatory compliance. It offers career growth, skill enhancement, and the chance to contribute to quality excellence for leading clients worldwide. Graduates seeking Pharmaceutical Science Jobs or Pharmacy Jobs can apply now.
