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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Specialist QA CSV - Computer System Validation

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 natural-science, technical, or IT-related background, or an equivalent vocational qualification 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.
  • Strong interest in IT topics.
  • Clear and proactive communication, logical thinking, and a solution-oriented working style.
  • Very good written and spoken German and English, at least B2 level.

Responsibilities

  • Assess 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 according to internal requirements and regulatory expectations.
  • Contribute to projects on 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 in customer audits and regulatory inspections and answer subject-matter questions.
  • Work closely with local departments, IT, global computer system validation and IT teams, and partner sites.

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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