Full-Time
Quality Assurance Specialist
Computer System Validation
Simtra BioPharma Solutions
Sterile injectable drug manufacturing
No salary listed
Halle, Germany
In Person
Financial relocation support is available for a work-related move.
Bachelor's, Master's
 Biology & Biotech (1) |
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- A completed Bachelor's, Master's, or Diplom degree with a scientific, technical, or IT-related background, such as a STEM field, or equivalent vocational training combined with professional experience.
- Ideally, at least two years of experience in data management, IT systems, or computer system validation/computer software assurance in a regulated environment.
- Initial experience in a good manufacturing practice environment and knowledge of relevant regulatory requirements and guidelines are advantageous.
- A strong interest in IT topics.
- Clear and proactive communication, logical thinking, and a solution-oriented way of working.
- Very good written and spoken German and English skills at least at B2 level.
- Evaluate existing, new, or changed IT systems, applications, databases, and tools for validation or computer software assurance relevance.
- Plan, coordinate, and conduct computer system validation and computer software assurance activities in accordance with internal requirements and regulatory expectations.
- Contribute to projects involving computer system validation requirements, including risk-based assessment, documentation, and follow-up.
- Review and maintain relevant computer system validation documentation, standard operating procedures, and process descriptions, and contribute to continuous improvement of the computer system validation program.
- Support root-cause analyses, corrective and preventive action definitions, and impact assessments for computer system validation-related deviations.
- Contribute to key performance indicators, trend analyses, and reports on the effectiveness and robustness of the computer system validation program.
- Present computer system validation and computer software assurance topics during customer audits and regulatory inspections and answer technical questions.
- Work closely with local departments, information technology, global computer system validation and information technology teams, and partner sites.
- Initial experience in a good manufacturing practice environment.
- Knowledge of relevant regulatory requirements and guidelines.
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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