Quality Management Specialist
vor 2 Monaten
Institut für Transfusionsmedizin Suhl Gemeinnützige GmbH is a leading nonprofit organization in the field of transfusion medicine, employing over 250 staff members across three locations in Germany. With a rich history of 60 years, our mission is to provide high-quality blood and plasma derivatives to healthcare facilities nationwide.
We are seeking a highly skilled Quality Management Specialist to support and enhance our quality management system.
- Develop and implement quality management strategies to ensure compliance with regulatory requirements
- Assist in projects, certifications, and accreditations to maintain our high standards
- Manage and develop standard operating procedures to optimize our processes
- Process and evaluate change control requests, deviations, and complaints to ensure quality and safety
- Collect and analyze statistical data for quality control, including creating product quality reviews, quality management manuals, and site master files
- Coordinate self-inspections, customer and authority audits, and follow-up on corrective actions to maintain our reputation
- Monitor validations and qualifications to ensure our products meet the highest standards
- Qualified vocational training with experience in quality management
- Background in natural sciences, technology, or business administration preferred
- Prior knowledge/experience in GMP/QM or drug approval beneficial
- Understanding of modern quality management in drug manufacturing
- Proficiency in statistical methods, quality tools, and project management
- English proficiency and proficient in MS Office
- Competitive salary with additional benefits
- Holiday and Christmas bonuses
- Monthly gas card
- Flexible working hours, possibility of home-office
- Attractive company pension plan
- Opportunities for professional development
- Pleasant work environment in a modern IT setting
- Free employee parking with on-site electric vehicle charging station
We look forward to discussing further details about the position with you.
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