Pharmaceutical Quality Complaint Specialist
1 week ago
Objective
The individual will be part of AbbVie's global quality team, focusing on the processing of complaints and inquiries related to pharmaceutical products, medical devices, and combination products.
Engagement with both internal and external stakeholders, including healthcare professionals, purchasing agents, and regulatory bodies, is essential for addressing product complaints effectively.
Key Responsibilities1. Ensure that all complaint records comply with global standards.
2. Conduct thorough documentation, investigation, and assessment of all non-medical complaint information. Review medical complaints that pertain to non-medical quality issues.
3. Guarantee that documentation adheres to Good Documentation Practices as well as Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). This role demands strong analytical capabilities, technical writing skills, and meticulous documentation practices.
4. Identify potentially reportable incidents and communicate findings to relevant departments and management.
5. Collaborate with Third Party Manufacturers, healthcare professionals, and various internal departments to ensure compliance and quality assurance.
6. Deliver exceptional customer service by coordinating the return of samples for investigation and managing follow-up actions, including product replacements, complaint categorization, and Corrective and Preventive Actions (CAPA).
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