Overview
In this role you will safeguard quality standards across the quality management system in a Biopharma setting. You will lead internal audits, drive CAPA with cross-functional teams, and ensure regulatory compliance. You will train colleagues on QA processes, sharing best practices. You will shape quality systems in a sterile environment and contribute to the company’s quality excellence journey.
Responsibilities
- Oversee and maintain the quality management system to ensure compliance with industry standards
- Conduct internal audits and inspections to identify areas for improvement
- Collaborate with cross-functional teams to implement corrective and preventive actions
- Provide training and guidance on quality assurance processes and best practices
Key requirements
- Relevant degree in a scientific or technical discipline
- Proven industry experience in quality assurance within a Sterile environment
- Working knowledge and practical experience with quality management systems and regulatory requirements
- detail-oriented
- strong analytical skills
- proactive problem-solving
- Quality Management Systems
- regulatory requirements compliance
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