- 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.
- Creates and reviews documentation to assure it meets GMP standards and can be used for regulatory filings and/or reporting. Examples include: Medical Device Reports and Ministry of Health inquiries.
- Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.
- Serve as main resource for the team or a subject matter expert on complaint handling.
- 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 for word processing and complaint management.
- Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
- A Bachelor Degree required or 3-5 years of relevant work experience. Preferred degree in nursing, pharmacy, medical technology, engineering or scientific background(MLT, LPN, RN).
- 2+ years’ work experience in a cGMP related industry or in a clinical setting is preferred
- Expertise in complaint handling and process.
Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced