Complaints Investigation Specialist II

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Complaint Specialist will provide technical leadership and subject matter expertise for the complaints department. This role will focus on overseeing complaint investigations, as well as assisting with metric tracking, complaint trending, complaint reviews including reviewing for potential regulatory reporting, and the issuance and tracking of Field Alert Reports (FARs) assessments.

ESSENTIAL DUTIES AND ROLE RESPONSIBILITIES

• Serve as the subject matter expert for Quality Management System (QMS) complaint module.
• Assist with metric tracking including metrics reported at Tier meetings, monthly reviews, and quarterly reviews (i.e. Quality Management Review)
• Review complaints to determine if regulatory reporting is required, and issue reports (i.e. FAR assessments) as required by site procedures, quality agreements, and applicable regulations.
• Review and assist in complaint investigations and provide corrections and feedback to ensure that investigations are error-free, comprehensive, and aligned with procedural and regulatory requirements.
• Serve as the complaint trend analyst for the site which includes the following responsibilities: Author complaint trend reports, perform an ongoing analysis of potential emerging trends, assess critical complaints for potential new failure modes and lead meetings to communicate complaint trending to upper management.
• Provide complaint data, memos, and other requested documentation for PQRs, etc.
• Contribute to activities related to Post-Market Surveillance, Field Alert Reports, and Adverse Event Reporting.
• Lead continuous improvement projects relevant to the department.
• Ensure complaint handling complies with regulatory requirements (i.e. FDA 21 CFR 210, 211, 820, ISO 13485, GMP) and internal procedures.
• Ensure timely and professional handling of customer concerns.

REQUIRED SKILLS AND EXPERIENCE

• Minimum of 4 years work experience in pharmaceutical quality, regulatory or complaint handling roles or Bachelor’s (science-based field preferred)
• Quality Assurance experience within the pharmaceutical industry
• Experience performing product complaint investigations
• Experience with product trend analysis
• Experience with technical writing
• Experience with continuous improvement projects and initiatives
• Proficient in Excel and Minitab
• Working knowledge of cGMP, ICH guidelines, 21CFR Part 210, 211, 820, EU GMP

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