Quality Associate Job at Fortrea | Life Sciences | Apply Now
Fortrea (formerly a part of Labcorp) is seeking a Functional Quality Associate II to join its specialized team in Mumbai. This quality associate job is central to ensuring the integrity of drug safety data and regulatory submissions for global pharmaceutical and biotechnology clients. A Fortrea career offers professionals in the Life Sciences the chance to work within a leading Clinical Research Organization (CRO) that manages the entire adverse event process for both investigational and marketed products.
- Job Position: Functional Quality Associate II
- Location: Mumbai
- Job Requisition ID: 256051
About the Company
Fortrea is a leading global provider of clinical development and patient access solutions. Formerly the Clinical Development and Commercialization Services business of Labcorp, Fortrea operates as an independent company focused on accelerating life-changing therapies to patients. Working at Fortrea provides exposure to a vast array of therapeutic areas and a culture dedicated to GxP compliance and process excellence.
Job Overview
The postholder is responsible for rigorous quality review of safety reports and medical documentation, ensuring that all services are safe, cost-effective, and compliant with international legal standards, such as the Health and Safety at Work Act 1974.
Core Responsibilities:
- Quality Review of Safety Reports: Perform ongoing reviews of safety reports for global regulatory submissions, including IND Annual Reports, PSURs, PADERs, and Clinical Study Reports.
- CAPA Management: Assist in preparing Corrective and Preventive Actions (CAPA) and ensure that results are documented and implemented in coordination with project managers.
- Metric Analysis: Compile quality metrics to identify trends and suggest strategies for process excellence and improvement.
- Adverse Event Oversight: Manage expedited adverse events, Product Quality Complaints (PQCs), and medical information queries, ensuring timely submission to regulatory agencies.
- Audit & Inspection Support: Coordinate with project teams to support clients during regulatory inspections and external audits.
- Training & Mentorship: Assist in designing training schedules for new hires and guide safety associates in managing call intake and documentation of dialogues.
Qualifications & Experience
To be eligible for this Life Sciences job, candidates must meet the following academic and professional benchmarks:
Educational Requirements:
- Bachelor’s, Master’s, or PhD degree in Life Sciences or Biological Sciences.
Minimum Experience:
- 2+ years of experience in the pharmaceutical, biotech, or CRO industry.
- Primary background in Pharmacovigilance (PV) or Safety Writing.
- Prior experience in Peer Review or Quality Review is required.
Technical Knowledge:
- In-depth understanding of case processing and assessment.
- Proficiency in ICH Guidelines, Good Clinical Practice (GCP), and Good Pharmacovigilance Practices (GVP).
- Knowledge of worldwide regulatory requirements for both marketed and investigational products (FDA and EU guidelines).
- Experience in generating quality metrics and trend analysis is highly preferred.
Landing a quality associate job at Fortrea in Mumbai is a strategic move for professionals with a strong foundation in Pharmacovigilance and regulatory standards. This Life Sciences job offers deep involvement in the safety reporting lifecycle, from metric analysis to CAPA implementation for global clinical trials. If you possess a degree in Medicine or Pharmacy and have over two years of experience in safety writing and peer review, this Fortrea career opportunity provides a platform to drive process excellence in the global biotech industry.
