· To assure QA oversight on the service provided for respective clients in line with
procedural documents along with applicable regulatory requirements and that any risk to Mitocon Biopharma business is being mitigated with appropriate documentation.
· To develop and analyse Key Performance Indicators (KPI) for quality and compliance of respective department. Also, report KPIs to applicable clients and management (as applicable).
· To act as a team member of the Quality Assurance team, giving input to for better quality improvement.
· To ensure reports and action plans are developed and completed within timelines mandated in Mitocon Biopharma procedures.
· Develop/improve and manage quality systems that includes creation/revision of appropriate Procedural Documents.
· Maintaining key QA systems such as Investigations, Deviations, Corrective action/Preventive Action (CAPA), Self-Inspection, Trainings,
Business Continuity, etc. and, developing and managing integrated Quality Management Plans.
· To maintain Pharmacovigilance System Master File and Its related annexures for Quality Assurance.
· Support in Regulatory Inspection and Client Audit.
· Participate in internal meetings with management and with client (as needed).
· Ensure adherence to the timeline and workflow of OneQMS as per requirements and provide cross-functional support for OneQMS operations.
Secondary Responsibilities
· Interfaces with other departments (e.g., Pharmacovigilance, IT, HR) regarding safety data collection, analysis, and reporting.
· Ensures data quality by overseeing or performing quality checks.