Quality Assurance Specialist
vor 1 Woche
The Quality Assurance Specialist plays a critical role in ensuring that our products meet the highest standards of quality and regulatory compliance. As a key member of our Clinical Supplies Team, you will be responsible for reviewing and releasing incoming label stock, clinical finished goods, and batch records to ensure that they meet our quality and regulatory requirements.
Key Responsibilities:- Review and release incoming label stock, clinical finished goods, and batch records
- Collaborate with internal functional areas and external partners to ensure quality compliance and identify potential areas for improvement
- Communicate batch-related issues to management and regulatory authorities
- Support quality walkdowns, GEMBA walks, and walkthrough audits to sustain continuous improvements efforts
- Bachelor's or Master's Degree in life sciences, ideally in biotechnology, biology, or pharmaceutical studies
- Minimum of 2 years' experience in GMP environment within the pharmaceutical or related industry
- Experience in batch record review is strongly recommended
- Excellent understanding of GMP and GDP
- High sense of accuracy and very good time management skills
- Professional and precise communication to local and global stakeholders in English; German is a big advantage
- Proficiency with SAP and MS Word/Excel as well as Six Sigma tool is preferred
- Willingness to drive issue-resolution
As a Quality Assurance Specialist, you will have the opportunity to work in a renowned company in the pharmaceutical industry and contribute to the development of novel biopharmaceuticals. Our hybrid work model offers a great balance between work and personal life.
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