Full-Time
Quality Assurance CAPA 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 completed Bachelor's, Master's, or Diplom degree with a natural-science or technical background.
- At least 2 years of professional experience in Quality Assurance or related areas is desirable.
- Knowledge of aseptic manufacturing and Good Manufacturing Practice is desirable.
- Experience with Veeva or comparable quality-management solutions is advantageous.
- Very good communication skills, logical thinking, and a solution-oriented approach are required.
- Very good German and English skills in speaking and writing are required.
- Present deviation details to customers and answer follow-up questions while representing Simtra's perspective.
- Coordinate the investigation strategy with the investigation lead.
- Review deviation reports from quality and customer perspectives.
- Approve deviations and Corrective and Preventive Action measures in the quality-management system.
- Contribute to compiling data and collecting quality metrics for CAPA and deviation management.
- Continuously optimize deviation and CAPA management to reflect customer, regulatory, and site quality requirements.
- Present the process during customer audits and regulatory inspections.
- At least 2 years of professional experience in Quality Assurance or related areas.
- Knowledge of aseptic manufacturing and Good Manufacturing Practice.
- Experience with Veeva or comparable quality-management solutions.
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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