
Complaint Management Specialist
1 day ago
We are seeking an experienced Complaint Management Specialist to join our team. As a key member of our organization, you will be responsible for handling product technical complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products.
- You will collaborate with internal/external stakeholders, including cross-functional teams, manufacturing sites, customer service, medical information, pharmacovigilance, sales associates, regulatory, commercial operations, legal, and risk management departments.
- Your duties will include ensuring timely completion of all training, entering complaints into the global database, evaluating complaints for severity and risk, and ensuring timely processing and closure of complaints.
- You will participate in ad-hoc meetings for product-specific complaint issues and provide timely feedback on complaint investigations.
- Additionally, you will manage and ensure compliance of all quality processes and documentation with applicable regulations and standards.
- You will proactively identify areas for improvement and support implementation.
In this role, you will also be responsible for:
- Managing QMS records and ensuring discrepancies are addressed within defined timelines.
- Preparing and updating data (timeline quality KPIs) periodically for team meetings.
- Supporting team initiatives and continuous improvement projects.
To be successful in this role, you will need:
- A minimum of 3-7 years of related experience in the pharmaceutical industry.
- Knowledge of cGMPs, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools.
- Bachelor s or Master s degree in Life Sciences, Healthcare, Business Administration, Engineering, or Information Technology.
- Proficient problem-solving skills, attention to detail, and organizational abilities.
- An analytical mindset and ability to multitask in a fast-paced environment.
This role offers a competitive salary, comprehensive benefits package, and opportunities for career growth and development.
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