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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Quality Assurance Specialist Manufacturing - Focus: Batch Record Review

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

About the Job

Requirements

  • A completed degree in a natural science field, such as chemistry or pharmaceutical engineering, biotechnology, pharmacy, or food technology, or comparable scientific vocational training.
  • At least 2 years of professional experience in the pharmaceutical industry; experience in aseptic manufacturing is an advantage.
  • Good knowledge of international current Good Manufacturing Practice regulations.
  • Strong communication skills to support collaborative work with production departments.
  • Strong quality awareness and solution-oriented working practices.
  • Knowledge of electronic Quality Management Systems such as Veeva or TrackWise is desirable.
  • Very good German and good English language skills, spoken and written.

Responsibilities

  • Conduct formal and substantive reviews of master batch records for sterile and aseptic products, including manufacturing and packaging records.
  • Ensure Good Manufacturing Practice compliance with EU GMP, FDA requirements, and internal quality standards.
  • Review manufacturing records covering sterilization, media fills, and aseptic filling; conduct audit trail reviews for electronic systems and review alarm logs.
  • Verify completeness and accuracy of product-related GMP documents, including sterilization records, cleaning records, sample sets, and sampling plans.
  • Ensure that all critical process parameters and release criteria have been met.
  • Review packaging records during final inspection in close coordination with PPV, QA Document Control, and Qualified Persons.
  • Check variable data in packaging records before their transfer to production, as well as appendices 4 through 6 of SOP-00585d.
  • Report deviations and support their root-cause analysis.
  • Enter data to collect key performance indicators and record processing times.

Desired Qualifications

  • Experience in aseptic manufacturing.
  • Knowledge of electronic Quality Management Systems such as Veeva or TrackWise.

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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