Company Profile
A market leading manufacturing organisation, operating across 100 countries worldwide. Through product innovation and operational excellence, they continue to expand and increase their market share worldwide.

Position Expectations
• To process customer complaints in accordance with company policy and procedure to drive towards
accurate and satisfactory resolution.
• To interact with all areas of the business in order to co-ordinate customer complaint investigations and information gathering to identify incidents of non-conformance to support the company continual improvement and corrective action programme while maintaining an overall vigilance of compliance and the principles of current Good Manufacturing Practices (cGMP).
• To oversee the site CAPA system, ensuring that investigation and root causing is performed to target timelines/in conjunction with risk factor and that corrective actions are complete in line with due dates.
• Member of internal auditor team

Key Areas of responsibility

• To process customer complaints in accordance with company policy and procedure, assigning investigation/action to appropriate personnel and where necessary perform the investigation of the complaint.
• To review the outcome of the investigation for suitability and adequacy regarding resolution of the complaint and determining further investigation/follow-up where deemed appropriate.
• Ensure any samples received regarding the complaint are properly handled and stored.
• To liaise with the Quality Manager on issues of non-conformance or non-compliance resulting from a customer complaint, identifying the need for CAPA and raising with Management.
• To adequately identify any samples relating to Customer Complaints to allow traceability to the complaint file and vice versa.
• Identification of archive sample storage to allow timely sample retrieval in accordance with company procedure.
• To provide oversight of Solutions CAPA system, developing a system for monitoring CAPA investigations and corrective actions and co-ordinating activities to assist with their progression.
• Ensure that effectiveness of CAPA is performed according to review dates and that CAPAs are accordingly closed or re-opened as appropriate.
• To provide data related to customer complaints and CAPA as directed by the Quality Manager to support reporting of Quality Key Performance Indicators.
• To perform and report internal audits to support the internal audit plan and ensue completion and effectivity of corrective actions raised from internal audits.

Knowledge, Skill and experience

• Computer literate, familiarity with and regular use of MS Office – Word, Excel.
• Ability to build and maintain internal and external working relationships.
• Well-developed communication skills to handle and convey complex information.
• Minimum of 2 years QA/QC experience within a Medical device or Pharmaceutical company
• Diligent and good attention to detail.
• Highly organized approach to working
• Experience and familiarity with Quality Management Systems for Medical Devices (ISO13485).
• Previous experience in complaints handling desirable.
• Previous experience of CAPA systems desirable.