Quality assurance- Complaints Specialist

Healthcare Businesswomen’s Association; Santo Amaro; Presencial; BRL 40.000 - 80.000; Tempo integral

Resumo da oferta

An established industry player is seeking a dedicated quality management professional to oversee compliance and quality assurance in pharmaceutical projects. This role involves managing complaints, ensuring timely release of products, and collaborating across departments to uphold the highest quality standards. If you have a background in QC/QA and a passion for continuous improvement, this position offers an exciting opportunity to contribute to impactful projects in a dynamic environment. Join a team committed to excellence and innovation in healthcare.

Qualificações

• 3+ years of experience in complaints and investigations.
• Experience in QC/QA within pharmaceutical or biotech industries.

Responsabilidades

• Manage quality aspects and projects ensuring GxP conformity.
• Handle complaints and ensure proactive communication.
• Develop reports for complaint management and regulatory decisions.

Conhecimentos

Continuous learning

Dealing with ambiguity

GMP procedures

Quality assurance (QA)

Quality control (QC) testing

Understanding of quality standards

Self-awareness

Technological expertise and intelligence

Descrição da oferta de emprego

Job Description Summary

Manages quality aspects and projects within the area of responsibility. Ensures and supports overall GxP conformity and compliance with the Novartis Quality Management Systems.

About the role :

• Ensure on-time and GMP-compliant release of dosage forms
• Handle complaints about inspections by authorities within your area of responsibility, ensuring issues are noticed and communicated proactively
• Responsible for complaint management, including entry, follow-ups, product analysis, and closure
• Develop and establish reports for prompt review of new complaints, regulatory reporting decisions, and follow-up actions
• Code events and ensure all required information for a complaint file is obtained and properly documented
• Evaluate all information from clinical and technical perspectives to ensure appropriate analysis, investigation, root cause analysis, and quality engineering review
• Track, receive, and ship products as needed
• Execute daily complaints analysis and failure investigations, documenting results and relevant information
• Approve complaints in assigned product families
• Set up complaint meetings and communicate effectively with worldwide complaint groups and internal departments

Minimum Requirements:

• Functional breadth in complaints and investigations
• At least 3 years of experience in complaints and investigations
• Experience in QC/QA within pharmaceutical or biotech industries, including environmental monitoring
• Ability to collaborate across boundaries and maintain cleanliness zones

Skills:

• Continuous learning
• Dealing with ambiguity
• GMP procedures
• Quality assurance (QA)
• Quality control (QC) testing
• Understanding of quality standards
• Self-awareness
• Technological expertise and intelligence

Languages :

• English

Skills Desired

Continued learning, dealing with ambiguity, GMP procedures, QA, QC testing, quality standards, self-awareness, technological expertise, and technological intelligence.