Quality Complaints Investigator — RCA & CAPA Lead

Mirus Consulting Group; Juncos (PR); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

mîrus Consulting Group seeks a highly qualified Specialist Quality Complaints to support complaint management in a regulated pharmaceutical environment. The successful candidate will lead investigations, perform root cause analyses, drive CAPA determinations, and ensure compliance with quality standards and regulatory requirements.

You will collaborate with cross-functional teams across Manufacturing, QA, QC, Engineering, Regulatory Affairs, and other functional groups to ensure timely,

Qualifikationen

• Experience in complaint handling, quality investigations, or quality systems within regulated industries.
• Strong project management with ability to manage multiple investigations concurrently.
• Expertise in root cause analysis methods and CAPA determinations.
• Deep understanding of quality systems, GxP regulations, and compliance requirements.
• Excellent problem-solving, analytical, and decision-making skills.
• Effective verbal and written communication skills.
• Strong interpersonal skills for cross-functional collaboration.
• Proficiency with Microsoft Office applications, including Excel and Outlook.
• Experience using Microsoft Teams for collaboration and communication.

Aufgaben

• Lead and coordinate product quality complaint investigations from initiation through closure.
• Perform comprehensive root cause analyses using structured problem-solving methodologies.
• Develop, assess, and support CAPA plans to address identified issues and prevent recurrence.
• Ensure complaint records, investigations, and associated documentation comply with internal procedures and regulatory requirements.
• Collaborate with Manufacturing, Quality Assurance, Quality Control, Engineering, Regulatory Affairs, and other functional groups to support investigations and implement corrective actions.
• Track investigation milestones and drive timely execution of commitments through effective project management practices.
• Evaluate complaint trends and identify opportunities for continuous improvement.
• Support internal audits, inspections, and regulatory inquiries related to complaint handling processes.
• Present investigation findings and quality recommendations to management and cross-functional stakeholders.
• Maintain a strong focus on compliance, patient safety, and product quality.

Kenntnisse

Root cause analysis

CAPA determination

Project management

Quality investigations

GxP compliance

Problem solving

Communication skills

Cross-functional collaboration

Regulatory awareness

Ausbildung

Doctorate degree

Master's degree with 2 years related experience

Bachelor's degree with 4 years related experience

Tools

Microsoft Office

Microsoft Teams

Jobbeschreibung

mîrus Consulting Group seeks a highly qualified Specialist Quality Complaints to support complaint management in a regulated pharmaceutical environment. The successful candidate will lead investigations, perform root cause analyses, drive CAPA determinations, and ensure compliance with quality standards and regulatory requirements.

You will collaborate with cross-functional teams across Manufacturing, QA, QC, Engineering, Regulatory Affairs, and other functional groups to ensure timely,