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. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.
Identification of potentially reportable events and notification to appropriate functional groups and management.
Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.