Analyst, Customer Complaints – 2306148591W
Description
Position Summary:
General Objectives
The overall objective of this position is providing temporary support in execution of complaint investigation processes and support in diverse Quality Assurance activities, under the direct supervision of the EQ P&O Team (Complaints).
The temporary support position is responsible to coordinate the complaint investigations related to External Supply Integration Quality and perform follow-up.
The position will monitor the investigation process for continuous improvement and measure key process indicators to assess the investigation process.
The position is responsible to actively develop and sustain partnerships with manufacturing and packaging sites, PQV and External Manufacturers to insure harmonized and consistent complaint investigation practices and understand the needs for future improvements.
The position will contribute to the overall implementation and execution of the TrackWise system or any system in use for complaint handling in support complaint handling flow of the external manufacture of pharmaceutical products.
The position may provide QA support to the EQ P&O Team, if needed, and contribute to the overall development, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical products.
Specific Objectives
Coordinate the complaint handling process to ensure on-time closure.
Review and monitor customer complaints in the respective database.
Interaction with the complaint handling department of the external manufacturer to follow-up on investigations.
Serve as a contact point within the QA organization of other departments of both Janssen and the external manufacturer with respect to complaint handling and quality relevant subjects.
Liaise with the account owners on more complex technical issues & questions.
Pro-actively identify risks and potential issues and delays and, where possible, resolve them. Where resolution is not possible, escalation to the EQ P&O Team if necessary.
Collaborate closely with respective EQ Complaints Manager and pro-actively seek advice and approval from EQ Complaints Manager in case of doubt.
Process and analyze product complaints according to Policies and Standard Operating Procedures.
Manage Product Quality Complaints to ensure standard process is followed, and data is consistent and of high quality, to assist with correct decision making.
Evaluate product quality complaints for seriousness, correctness, and consistency of categorization.
Communicate with External Business Partners to ensure timeliness and review their investigation report for accuracy and completeness.
Partner with stakeholders (JJQS, PQV, Internal JSC Manufacturing Sites, External Business Partners, Regional EQ organizations, Call Intake Centers, Global Medical Safety/LSOs, Marketing, Sales Administration, Brand Protection, etc.) to gain knowledge of products and processes.
Develop and generate reports associated with the Quality Complaint Handling System and associated processes.
Manage field sample process including documentation, evaluation, and disposal, as applicable.
Support internal and external audits and inspections.
Participate within special projects.
Attend Monthly meeting/ trainings/calls.
Qualifications
Minimum Qualification
Minimally basic degree in Science, Engineering and Technical subjects, or equivalent.
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
Excellent computer proficiency e.g MS Office, SAP
Excellent analytical skill to identify gaps and root causes of issues , and think out of the box to develop a solution.
Must be able to work independently with minimum supervision to meet tight deadlines, and maintain a positive attitude.
Primary Location Europe/Middle East/Africa-Ireland-Dublin-Dublin
Other Locations NA-United States, Europe/Middle East/Africa
Organization Janssen R&D Ireland (7566)
Job Function Quality Assurance
Req ID: 2306148591W
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