Full-Time
Quality Assurance Document & Training 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 a comparable qualification such as a state examination in pharmacy, or a scientific vocational qualification such as laboratory technician or pharmaceutical technician.
- At least 2 years of professional experience in Quality Assurance is desirable.
- Strong knowledge of Good Manufacturing Practice is advantageous.
- Very good German and English language skills are required.
- Strong communication skills and a structured working approach are required.
- Manage the training and document management systems, such as learning management systems and document management or electronic quality management systems.
- Coordinate and ensure Good Manufacturing Practice-compliant training processes.
- Manage the complete lifecycle of Good Manufacturing Practice documentation.
- Support and train users, document owners, and stakeholders.
- Develop and monitor relevant key performance indicators.
- Support the implementation of global standards and processes.
- Participate in or lead site-specific projects.
- Support inspections and audits as a subject-matter expert.
- Implement continuous-improvement measures.
- Experience in document and training management is ideal.
- Experience with electronic quality management systems such as Veeva or TrackWise is desirable.
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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