Senior Quality Assurance Specialist

The Customer Complain Field: -

• Act as a focal point for customer complaints.
• Make Necessary Investigation & Traceability for the Complaint.
• Maintain CAPA based on the Complain case.
• Preparing documentation and maintain a filing system related to customer complaints.
• Support in liaising and negotiating with regulatory authorities.

The Non-Conformity Reports (NCR)Field: -

• Receive the Non-Conformity Report (NCR) & Record NCR details in the related log sheet
• Start the Investigation with the response and follow up till reaching the final Root Cause.
• Identify the need for issuing Corrective and Preventive Action (CAPA) related to non-conformity.
• Closing the Non-Conformity Report after taking necessary actions to prevent re-occurrence.

The Corrective and Preventive Action (CAPA) Field: -

• Open The Corrective and Preventive Action (CAPA) Case by Implementing the Corrective and Preventive Action Report.
• Follow Up & Investigate the Corrective and Preventive Actions (CAPA).
• Record the Corrective and Preventive Actions (CAPA) in The Corrective and Preventive Action Follow Up Sheet & The Corrective and Preventive Action Plan Log
• Apply Root Cause Analysis methods to identify the root cause.
• Evaluate the Efficiency of the performed Corrective and Preventive Actions and Close the CAPA Case.

The Internal Audit Field: -

• Perform the Internal Audits after Notifying the Auditee Department as per the predetermined plan or unannounced.
• Prepare the Final report of The Internal Audit
• Non-ConformitiesFollow up the Corrections and the performed Corrective / Preventive Actions by the Related Department for closing any Non-Conformities (If Present)