Sr. Specialist Quality Compliance @ Pfizer

• 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 crossfunctional 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.

Additional Responsibilities:

• Participates and contributes as a team member and takes responsibility for a portion of the teams milestones/ deliverables.
• Followup 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.