Our client, a leading biopharmaceutical company, is keen to hire a Complaint Processing Analyst to join their growing team in Mayo on a 12-month contract.
Reporting to the Complaints manager, the Complaint Processing Analyst will coordinate the handling of customer complaints investigations and is responsible for coordinating cross-functional activities in the investigation of Adverse Event/ Product Quality.
Key Responsibilities of a
Complaint Processing Analyst:
Assure complaint records meet global requirements.
Product complaint documentation, investigation, and review of all non-medical complaint content.
Responsible for reviewing medical complaints that involve a non-medical quality related problem.
Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP.
This requires good analytical skills, technical writing, and good documentation.
Identification of potentially reportable events and notification to appropriate functional groups and management.
Serve as main resource for the team or a subject matter expert on complaint handling.
Liaise with site complaint investigation team to achieve closure of complaint cases in a timely manner.
Attend all meetings as requested by the Complaints Manager or arrange an appropriate deputy.
Ideal Background:
Bachelor's degree in sciences or related field.1-2 years previous experience in pharmaceutical industry.
Previous experience in the use of SAP and Trackwise and Document management systems is desirable.
Knowledge of global regulatory requirements for pharmaceutical, medical device and combination products.
Strong CAPA knowledge, decision making and critical thinking abilities.
Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.
For a confidential discussion and more information on this Complaint Processing Analyst role, please contact Sarah Flynn.
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