Job Description

Summary This position is responsible for managing the activities and procedures associated with complaints in the Asia Pacific and/or North America region. He/she is accountable for the day to day complaint management processes, and review and evaluation of service complaint cases and work orders to determine if the information received meets the criteria for a product complaint and categorize the cases into complaint and non-complaint, and the RCC (Regional Complaints Center) operational activities to ensure that the quality system compliance requirements are met per the relevant Standards, Corporate and Local Regulation requirements. This position is also responsible for driving continuous process improvement in the APRCC using competencies such as LEAN Management System to support the needs of the business and its customer



II. Key Responsibilities

• Assist direct manager in management of managing the day to day complaint management processes, and review of Life Science service complaint/non-complaint cases and work orders, activities include:

• Prepare and analyze complaint trends for the country/region.
• Monitor and communicate significant quality trends and identifying adequate corrective actions.
• Provide internal awareness of noted trends and quality issues via periodic and ad hoc reports.
• Monitor and lead daily operation of AP RCC team as assigned

• Responsible for the management of the complaint handling process and the review of service complaint cases and work orders as assigned. Activities include:

• Review all Customer complaints about validity and assures complaints are processed in compliance with Company policies and procedures.
• Communicate and partner with the business team and technical team in customer management
• Complaint and non-complaint tracking and escalation management
• Implement and follow procedures to ensure timely and accurate receipt and review of service complaint and non-complaint cases and work orders.
• Implement and follow procedures to ensure timely and accurate receipt, logging, analysis, and response to customer complaints.

• Be a coach/mentor in the end-to-end complaint management process in GA region
• Represent AP RCC in cross-functional meeting/discussion relating to the end-to-end complaint management process as assigned
• Support AP RCC Team Lead in monitoring the Asia Pacific Regional Complaint Center Operational Metrics/Service Level Agreement (SLA) performance and ensure that the operational objectives and service level performance targets are consistently met.
• Collaborate with Business/Country/Function Leaders on customer complaints to ensure business objectives are met.
• Initiate, track, follow-up and close Corrective and Preventive Actions.
• Responsible for reviewing and documenting updates of BD\xe2\x80\x99s quality documents in accordance with quality related regulations, etc.
• Ensure the Customer complaint investigation, procedures, and activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance.
• Support APRCC team lead in planning and executing training plan for APRCC associates. Provide training to personnel involved in complaint investigation and complaint systems (such as Trackwise, Salesforce, Service-Max, etc.) users, as a directive by the Supervisor.
• Perform review of Adverse Events (injury complaints) for reportability to regulatory authorities for multiple countries according to BD procedures.
• Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering the course of action when and where necessary.
• Remain current in any upgrades to complaint handling systems.
• Comply with all ISO 13485 requirements and BD policies.

• Ensure a safe, healthy and environmentally friendly workplace by observing Company\xe2\x80\x99s rules and procedures. Active involvement in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement, and reduction of resource materials.
• Executes any tasks and/or projects as assigned by the Supervisor or higher management

III. Education

• Diploma or Bachelor degree in a Science, Engineering or Nursing discipline

IV. Other Qualifications - Professional Certification/Key Licenses

• Relevant quality assurance experience in quality systems for complaint management, failure investigation, corrective & preventive action, and document & quality records management.

V. Experience

• Minimum 5 years relevant quality assurance experience in the pharmaceutical or medical device manufacturing industry or healthcare; supervisory experience will be an added advantage

VI. Required Knowledge and Skills

• Knowledge in ISO 9000, ISO 13485 or US FDA QSR and should be able to guide and coach associates at respective work functions.
• Customer focus and must be able to identify and resolve problems and requests in a proactive and timely manner.
• Must be able to guide and coach associates in gathering and analyze information skillfully using problem solving/root cause analysis skills.
• Ability to exchange information clearly and concisely.
• Responsible to lead a project related to AP RCC improvements under the guidance of AP RCC Team Lead.
• Ability to guide, coach and advise associates who involved are in complaint investigation and complaint management systems (such as Trackwise, Salesforce, Service-Max, etc.) users, as a directive by the Supervisor.
• Drive for results and action oriented with a high sense of urgency
• Self-starter with the desire and ability to take initiative.
• Demonstrated ability to work independently under time constraints, manage competing priorities and deadlines, and handle multiple tasks efficiently and effectively.
• Ability to work in a large, fast-paced, matrixes organization with speed and accuracy.
• Ability to work well in a team-oriented environment.
• Fluent in spoken and written English.
• Good communication skills.
• Continuous and versatile learning.
• Able to use Microsoft Excel spreadsheet with knowledge of formulas.
• Ability to apply statistical analysis tools independently
• Able to use PowerPoint skills for creation/maintenance of organization charts and presentations.

Primary Work Location MYS Kuala Lumpur - Jalan Kerinchi

Additional Locations

Work Shift MY2 Standard (Malaysia)

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