Life Science Jobs: Fortrea Hiring a Functional Quality Specialist | Apply Now
If you’re searching for high-growth Life Science Jobs with real impact, this Fortrea Career opportunity as a Quality Specialist is a role you can’t overlook. This position offers the chance to work with global safety operations, advanced regulatory processes, and cutting-edge quality systems—all while shaping the future of clinical and post-marketing safety. With hybrid flexibility in Pune, this is your moment to step into a career built on excellence, innovation, and purpose.
Job Details:
- Job Title: Functional Quality Specialist I
- Location: Hybrid – Pune
- Time Type: Full time
- Job Requisition ID: 255882
About the Company
Fortrea is a leading global Contract Research Organization (CRO) dedicated to advancing clinical development, drug safety, and regulatory excellence. Known for its innovation-driven approach, Fortrea supports pharmaceutical, biotechnology, and medical device companies in bringing safe and effective therapies to market.
As a company committed to quality, scientific integrity, and patient safety, Fortrea offers unmatched opportunities for professionals pursuing meaningful Life Science Jobs. Its collaborative environment, advanced technology platforms, and global project exposure make it an ideal place to build a long-term Fortrea Career.
Fortrea’s work spans clinical trials, pharmacovigilance, functional quality operations, and comprehensive regulatory services. By empowering employees—especially those stepping into roles like Quality Specialist—Fortrea drives continuous improvement, delivers reliable outcomes for clients, and contributes significantly to global healthcare advancement.
Key Responsibilities
- Perform quality review of assigned cases.
- Compile quality metrics and identify quality trends.
- Support CAPA preparation, implementation, and documentation.
- Review global regulatory submissions including PSURs, PADERs, Annual Reports, CSRs, and more.
- Manage adverse event processing, medical information, and product quality complaints.
- Conduct process reviews and ensure audit readiness.
- Design and track training schedules and materials.
- Support internal/external audits and regulatory inspections.
- Guide safety associates in voice call management.
- Lead data analysis for process improvement initiatives.
- Respond to medical information and product quality queries.
- Execute drug safety data management processes.
- All other duties as assigned.
Educational Requirements
- Bachelor’s/Master’s/PhD in Biological Sciences, or Life Sciences.
- Equivalent experience may be considered.
Skills Required
- Strong understanding of GCP, GVP, ICH guidelines.
- Knowledge of worldwide regulatory reporting requirements.
- Expertise in case processing and safety documentation.
- Proficiency with Microsoft Office tools.
- Ability to anticipate problems and propose solutions.
- Strong communication and cross-functional collaboration skills.
- Experience with CAPA, quality metrics, and trend analysis (preferred).
- Knowledge of medical device reporting (preferred).
This Quality Specialist opening at Fortrea is a strong stepping stone for candidates seeking Life Science Jobs that blend regulatory expertise, safety operations, and quality excellence. If you want a Fortrea Career that empowers growth and global impact, this role brings the perfect balance of challenge, learning, and advancement.
