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.
sarah.flynn@collinsmcnicholas.ie
+353 719108060
#J-18808-Ljbffr