Sr. Specialist- Quality Compliance
Perform product quality complaint investigations in a timely manner to determine the root cause and recommend appropriate CAPAs.
Promptly assess the impact on product quality and patient safety due to the complaint defect. Evaluate and take necessary containment and corrective action.
Issue Notification to Management (NtM) for any issues related to product quality, compliance or market actions.
Assess the requirement of Field Alert Report and provide the required data for FAR submission.
Use various investigation techniques and tools to analyze the data critically to draw an inference in support of investigation.
Handle the complaints through electronic complaint management database.
Collate investigation reports as required from various cross-functional departments and conclude the complaint investigations.
Evaluate the complaint trend and take appropriate actions.
Assist and/or undertake investigations and apply relevant and necessary actions/systems to ensure appropriate levels of compliance.
Participates and contributes as a team member and takes responsibility for a portion of the teams milestones/ deliverables.
Follow-up on corrective actions/preventive actions derived from Regulatory Inspections and Third party or Corporate Assessments through completion.
Maintain the Inspection Readiness tracker and its timely update as per current information.
Preparation of the IR Meeting slide deck to present in site meetings and leadership meetings.
Responsible for scheduling governance meetings and notify any delays on time to management.
Coordinate with Engineering, Admin & IT to arrange back room and front room for inspections.
Collect and coordinate data for opening meeting presentation for Inspections or Assessments.
Provide data for preparation of metrics for Inspection Readiness and Regulatory Inspections actions status.