Functional Quality Specialist I | Regulatory Affairs Jobs at Fortrea | Apply Now
Fortrea is hiring a Functional Quality Specialist I in Pune for professionals seeking Regulatory Affairs jobs. This Fortrea job offers an exciting opportunity to ensure quality compliance in pharmacovigilance, safety writing, and regulatory operations. Ideal candidates will have experience in quality review and a passion for maintaining high standards in pharmaceutical projects. Join Fortrea and contribute to innovative healthcare solutions while advancing your career in Regulatory Affairs jobs.
Job Details:
- Job Title: Functional Quality Specialist I
- Remote Type: Hybrid
- Locations: Pune
- Job Requisition ID: 255882
About The Company
Fortrea is a global leader in providing innovative solutions and services in the pharmaceutical and biotech industries. Our mission is to deliver excellence and ensure safety in all our operations. With cutting-edge technology and dedicated professionals, we are committed to improving the quality of healthcare worldwide.
Job Description
The Functional Quality Specialist I role ensures adherence to high-quality standards in client projects, focusing on pharmacovigilance, regulatory submissions, and safety data management. This position is perfect for candidates seeking Regulatory Affairs jobs in a reputable organization.
Key Responsibilities
- Perform quality review of assigned cases and regulatory documents.
- Compile quality metrics, identify trends, and assist in corrective actions (CAPA).
- Support implementation of CAPA results with documentation evidence.
- Manage adverse events, product complaints, and medical information submissions.
- Conduct process reviews, track training schedules, and identify process improvements.
- Assist in client or external audits and regulatory inspections.
- Guide safety associates in case processing and call intake reviews.
- Execute drug safety data management and respond to medical queries.
- Review Annual Reports, Clinical Study Reports, Core Data Sheets, and other regulatory documents.
- Perform other duties to maintain high-quality standards in Regulatory Affairs jobs.
Qualifications Required For Regulatory Affairs Jobs
- Bachelor’s/Master’s/PhD in Pharmaceutical Science or related field.
- Relevant experience may substitute for formal education.
Experience
- Minimum 2+ years in pharmaceutical, biotechnology, or CRO industry in pharmacovigilance, safety writing, or quality review.
- Knowledge of GCP, GVP, ICH guidelines, and regulatory reporting standards.
- Ability to analyze trends, anticipate issues, and present actionable insights.
- Proficient in Microsoft Office and regulatory documentation processes.
Preferred Qualifications Include:
- Experience in generating quality metrics, CAPA reports, and trend analysis.
- Knowledge of medical device reporting is a plus.
