Specialist Quality Complaints

Career Category

Quality

Job Description

At Amgen Breda medicines are labelled assembled stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 42 different nationalities are working on supply chain processes manufacturing marketing and sales of our medicines and clinical research into new medicines.

Specialist Quality Complaints

Live

What you will do

We are seeking a Specialist Quality Complaints to join the Product Complaints and Surveillance team as a Complaint Owner. The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management system ensuring appropriate business connectivity across Amgen. The team is focused on maintaining complaint processes and systems in a compliant state through adherence to quality standards and procedures while meeting current and emerging internal and external addition the team leverages information from the market to drive continuous improvement initiatives.

As a Specialist Quality Complaints you will facilitate cross-functional teams in conducting both basic and complex complaint investigations determining appropriate corrective and preventive actions and assessing their effectiveness. You will also ensure the appropriate level of control for products in distribution and align complaint closure activities with established process metrics to support timely and compliant record closure.

Lets do this. Lets change the world.

In this vital role you will:

• Manage and investigate product quality complaints in compliance with applicable regulatory requirements and company procedures.
• Conduct complaint assessments trend analyses and documentation activities to ensure timely and accurate resolution.
• Facilitate cross-functional investigations and collaborate with Manufacturing Supply Chain Quality Assurance Regulatory Affairs and other key stakeholders to identify root causes and drive corrective and preventive actions (CAPAs).
• Ensure accurate complete and compliant documentation within quality management systems.
• Assess product impact and support decision-making related to product disposition and control in distribution.
• Monitor complaint performance metrics and ensure adherence to established timelines and closure requirements.
• Support Health Authority inspections and internal and external audits related to complaint management activities.
• Communicate investigation progress and outcomes to relevant stakeholders while maintaining high standards of quality and compliance.
• Analyze complaint data and trends to identify opportunities for continuous improvement and risk mitigation.
• Support the implementation and ongoing enhancement of global quality programs processes and best practices.

Win

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The Quality professional we seek is a collaborative and detail-oriented professional with these qualifications:

• Bachelors degree in Life Sciences Pharmacy Biotechnology Engineering or a related field.
• Relevant experience in Quality Quality Assurance Quality Complaints Manufacturing Supply Chain or a regulated pharmaceutical/biotechnology environment.
• Knowledge of GMP GDP and quality system requirements.
• Experience conducting investigations root cause analysis and CAPA management.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills in English.
• Ability to work effectively in a cross-functional and global environment.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.

Thrive

What you can expect of us

As we work to develop treatments that take care of others so we work to care for our teammates professional and personal growth and well-being. Therefore Amgen is regularly recognized as a Best Place To Work .

• Vast opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising competitive salary bonus structure fixed 13th month holiday allowance and a collective health insurance.
• Focus on vitality with an on-site gym vitality program and a restaurant with healthy food.

.

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1