Functional Quality Specialist I

Key Responsibilities

• Manage and review expedited adverse events, product quality complaints, and medical information to the required standard, ensuring submission to clients and regulatory agencies (if applicable) within agreed timelines.
• Assist in conducting process reviews for assigned processes and monitor audit readiness.
• Support the design and tracking of training schedules and preparation of training materials for new hires and existing team members.
• Contribute to discussion forums on quality errors within assigned projects and help identify process improvement opportunities.
• Coordinate client or external audits of assigned projects as requested.
• Assist in developing the Quality Management Plan for assigned projects.
• Collaborate with project teams to support clients during regulatory inspections at client sites, with guidance from the Quality Lead/Manager.
• Perform data analysis and, if required, suggest and implement process improvement strategies.
• Review data analysis performed by others and provide input to drive strategies for process excellence.
• Respond to or review medical information queries, product quality complaints, and general inquiries received via telephone, email, fax, etc.
• Review recorded information from multiple communication channels to ensure accuracy and compliance.
• Execute drug safety data management processes, including call intake review, call documentation review, and case follow-up.
• Guide safety associates in managing voice calls as required.
• Perform support activities such as tracking various types of information and metrics, ongoing quality control of defined process steps, training, and reconciliation of data from multiple sources.
• Review a sample of various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging Reports, Investigator Brochures, and relevant sections of protocols and Clinical Study Reports.
• Undertake any other duties as assigned, ensuring compliance and operational efficiency.