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 (Full description available upon request):
- 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 required 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