Full-Time
Quality Assurance Change Control 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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- At least two years of professional experience in Quality Assurance.
- Sound knowledge of Good Manufacturing Practice (GMP).
- Experience with electronic quality management systems such as Veeva or TrackWise.
- Knowledge of quality processes including Corrective and Preventive Actions (CAPA), deviations, and document management.
- Experience in risk analyses and data evaluation.
- Very good German and English language skills.
- An analytical and structured working style.
- Strong communication skills and assertiveness.
- Take responsibility for Quality System Change Control Management.
- Monitor and continuously improve the change-control process.
- Provide Quality Assurance approval for change controls and quality-relevant documents.
- Coordinate, assess, and track changes.
- Moderate the Change Control Governance Board.
- Ensure data integrity in the change-control system.
- Monitor relevant key performance indicators (KPIs) and quality metrics.
- Collaborate with international stakeholders and customers.
- Support Annual Product Quality Reviews (APQRs) and other reporting activities.
- Support audits and inspections.
- Train and advise employees.
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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