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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Technician - Quality Oversight Production

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeHalle, Germany

About the Job

Requirements

  • Completed vocational training as a pharmaceutical technician, chemical laboratory technician, or comparable qualification, or a degree in a natural-science field.
  • At least 2 years of professional experience in aseptic manufacturing is advantageous.
  • Very good knowledge of international current Good Manufacturing Practice (cGMP) regulations.
  • Strong communication, service orientation, and quality orientation.
  • Ability to work independently, carefully, and with a solution-oriented approach.
  • Proficient use of Microsoft Office and electronic quality management systems such as Veeva or TrackWise, with basic knowledge of enterprise resource planning systems.
  • Very good spoken and written German and English.
  • Willingness to work a rotating shift schedule.

Responsibilities

  • Conduct quality-assurance oversight in cleanrooms and production, as well as during inspection, labeling, packaging, and shipping.
  • Review manufacturing records, logbooks, environmental monitoring, and sterilization data.
  • Monitor and control cleaning processes and product segregation.
  • Release cleanrooms and production equipment following changes.
  • Initiate and support deviation investigations, corrective and preventive actions, and change controls.
  • Support regulatory-authority and customer audits, standard operating procedure updates, and continuous-improvement activities.
  • Collect data for trend analyses to implement continuous improvements.
  • Escalate critical matters to higher levels within quality assurance.

Desired Qualifications

  • At least 2 years of professional experience in aseptic manufacturing is advantageous.

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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