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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Team Lead Quality Assurance Computer Systems Validation - Computer Systems Validation, CSV

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeHalle, Germany

About the Job

Requirements

  • A completed Bachelor's, Master's, or Diplom degree with a science, technical, or IT-related background, such as a STEM discipline.
  • At least 5 years of experience in data management, IT systems, or CSV/CSA 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, is advantageous.
  • Very good spoken and written German and English.

Responsibilities

  • Take responsibility for the CSV area at the Halle site.
  • Implement current CSV/CSA guidelines and regulatory requirements at the site, continuously improve the CSV program, and develop and establish processes and SOPs.
  • Assess existing, new, or changed 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.
  • Contribute to projects on CSV requirements, including risk-based assessment, documentation, and follow-up.
  • Conduct CSV-related investigations for GMP deviations, define appropriate CAPAs, and assess impact.
  • Create and evaluate KPIs, trend analyses, and reports on the effectiveness and robustness of the CSV program.
  • Present CSV/CSA topics during customer audits and regulatory inspections, and respond to technical questions.
  • Work closely with local departments, IT, global CSV and IT teams, and partner sites.

Desired Qualifications

  • 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.

About the Company

Simtra BioPharma Solutions

Sterile injectable drug manufacturing

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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