Job Overview:
It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a protected and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.
Summary of Responsibilities:
Take ownership of assigned aspects of quality reviews on projects.
Compile metrics and identify quality trends.
Assist in addressing periodic client quality reviews and other ad-hoc client quality findings.
Prepare initial drafts of Corrective and preventive actions.
Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC’s, Med Guides etc.




Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports).
Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.
Take ownership of assigned CAPAs with respect to ensuring that the actions are closed and produce documentary evidence to that effect in coordination with the project managers.
Contribute to process reviews, own certain aspects of the reviews and use the results to help identify process improvements and develop process standards.
Contribute to designing and tracking training schedule and training material for new hires and existing team.
Help initiate discussion forums on Quality errors within as

📌 Functional Quality Specialist II (Pune)
🏢 Fortrea
📍 Pune