Description
Summary:- In compliance with current good manufacturing practices, the Product Complaint Associate is responsible for supporting the complaint handling Quality system through the timely assessment, processing, distribution of information, and communication of alleged product quality defects for all drug products within the scope of the Global Product Quality Complaints (GPQC) Group.
- Triage all received complaints in order to immediately identify any potentially expedited quality/compliance issues.
- Responsible for recording quality complaint information received into the global complaint database. This includes:
- Entering new complaints
- Determine when a complaint should be investigated or recorded for trending purposes only
- When a complaint sample should be retrieved for evaluation.
- Issue response letters to complainants regarding product complaints received.
- Complete daily workload while maintaining consistent, quality work and compliance with established procedure and timelines. This may require triage or action on a minimum number of complaints daily as specified by determined by the US Complaints Operations managers.
- Contact reporter, as necessary, to gather additional complaint information to ensure the site may adequately evaluate the alleged complaint.
- Complete required training within designated timeframes and participate in annual GMP training
Qualifications:
- Understanding of Code of Federal Regulation (CFR) good manufacturing practices for finished pharmaceuticals with emphasis on complaint handling requirements.
- Experience with computer systems including database, spreadsheet and word processing applications.
- Excellent oral and written communication skills
- Organizational skills
- Must be flexible with regard to changing and conflicting priorities, able to easily shift gears in response to ambiguity and the needs of the situation
- Must have ability to address obstacles with energy and determination and exhibit commitment to change and passion for the company's best interests