Full-Time
Quality Assurance Computer Systems Validation Team Lead
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 scientific, technical, or IT-related background, such as an STEM field.
- At least 5 years of experience in data management, IT systems, or Computer System Validation/Computer Software Assurance in a GMP environment.
- Knowledge of relevant regulatory requirements and guidelines, including EU GMP Annex 11, PIC/S PI 041-1, FDA Computer Software Assurance, ICH Q9(R1), ISPE GAMP 5 Second Edition, and ISPE Pharma 4.0.
- Very good written and spoken German and English skills.
- Own the CSV function at the Halle site.
- Implement current CSV/CSA guidelines and regulatory requirements at the site and continuously improve the CSV program, including developing and establishing processes and standard operating procedures.
- Assess existing, new, or modified IT systems, applications, databases, and tools for validation or CSA relevance.
- Plan, coordinate, and conduct CSV/CSA activities in accordance with internal requirements and regulatory expectations.
- Participate in projects involving CSV requirements, including risk-based assessment, documentation, and follow-up.
- Conduct CSV-related investigations within GMP deviations, define suitable corrective and preventive actions, and assess their impact.
- Create and evaluate key performance indicators, trend analyses, and reports on the effectiveness and robustness of the CSV program.
- Present CSV/CSA topics during customer audits and regulatory inspections and answer technical questions.
- Work closely with local departments, IT, global CSV and IT teams, and partner sites.
- Knowledge of the relevant regulatory requirements and guidelines, including EU GMP Annex 11, PIC/S PI 041-1, FDA Computer Software Assurance, ICH Q9(R1), ISPE GAMP 5 Second Edition, and ISPE Pharma 4.0.
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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