Functional Quality Specialist II Job in Pune at Fortrea

Fortrea is hiring for the role of Functional Quality Specialist II!

Responsibilities of the Candidate:

• 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 assigned project and identify process improvements, share best practices across projects.
• Assist in coordinating respective client or external audits of the assigned projects.
• Draft sections of the Quality Management Plan for assigned project.
• Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager.
• Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables.
• To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc.
• Review recorded information that may be received over the telephone call, email, fax etc.
• Execute drug safety data management processes – a combination of call intake review, call dialogue documentation review and case follow-up.
• Perform and Review of analysis of data performed and drive strategies for process improvement/excellence.
• All other duties as needed or assigned.