Full-Time
QA Supplier Quality Management Specialist
Simtra BioPharma Solutions
Sterile injectable drug manufacturing
No salary listed
Halle, Germany
In Person
Bachelor's, Master's
 Biology & Biotech (1) |
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- A Bachelor's or Master's degree in natural sciences, such as Pharmacy, Chemistry, or Biology, or an equivalent qualification such as the German State Examination in Pharmacy.
- At least 2 years of professional experience in Quality Assurance is desirable.
- Proficiency in Good Manufacturing Practice (GMP).
- Very good German and English language skills at least at C1 level.
- Manage and further develop the Supplier Quality Management System.
- Maintain supplier-related processes in the electronic Quality Management System (eQMS).
- Qualify, approve, and monitor supplier performance.
- Process supplier deviations, Corrective and Preventive Actions (CAPAs), and changes.
- Support and coordinate change-control activities.
- Create and manage Supplier Quality Agreements.
- Support regulatory inspections and customer audits.
- Contribute to Annual Product Quality Reviews (APQRs) and other quality reports.
- Collaborate closely with internal and external partners.
- Experience in supplier qualification.
- Experience with electronic quality management systems such as Veeva or TrackWise.
- Knowledge of quality processes such as Corrective and Preventive Actions (CAPA), deviations, and document management.
- A German State Examination in Pharmacy or another comparable qualification.
Simtra BioPharma Solutions is a contract development and manufacturing organization specializing in sterile injectable medicines. It supports pharmaceutical and biotechnology companies with formulation, process development, clinical and commercial manufacturing, filling, packaging and related technical services. Facilities and teams operate under regulated quality systems suited to complex parenteral products. Simtra is a business-to-business manufacturing partner rather than a consumer drug brand, helping sponsors move therapies from development into reliable supply through dedicated production expertise and capacity.
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