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Functional Quality Specialist I
3 months ago
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.
With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
- 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.
- Assist in the conduct of process review for assigned process and measure and monitor audit readiness.
- Assist in designing and tracking training schedule and training material for new hires and existing team.
- Contribute to discussion forums on Quality errors within assigned project and help identify process improvements.
- Assist in coordinating respective client or external audits of the assigned projects as requested.
- Assist in development of 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.
- Perform Analysis of data and if required, suggest strategies for process improvement/excellence.
- Perform and Review of analysis of data performed and drive strategies for process improvement/excellence.
- 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.
- Guide safety associates in managing voice calls (as required).
- Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources.
- Contribute to process review and use results to identify the process improvement initiatives.
- Coordinate with the project team to support sponsor during the regulatory inspections or audits as applicable.
- Review of product quality complaints, medical/general information queries and respond back to reporter/consumer as per agreed procedures and captures this information in required formats agreed with Sponsor.
- Review of a sample of various safety reports for global regulatory submissions for Fortrea clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports, Investigator brochures and sections of protocols, Clinical Study Reports etc.
- All other duties as needed or assigned.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.
Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
