Job Description 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. Qualifications Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products. Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred. Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred. Solid written/verbal communication and organizational skills. Knowledge and application of computer systems: MS word,excel Ability to work with cross-functional teams and to interact effectively with peers, management, and customers. A Bachelor Degree required or 1-2 years of relevant work experience. (Preferred degree in technology or scientific background) 0-2 years' work experience in a cGMP ( Good Manufacturing Practice) related industry or in a clinical setting (preferred) Additional Information AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
