Pharmaceutical Quality Control Expert

vor 4 Wochen

Leipzig, Sachsen, Deutschland GULP – experts united Vollzeit

Finding a suitable position can be straightforward: GULP – experts united is currently seeking a GMP Specialist to join our Batch Record Review team for a leading pharmaceutical client . We are committed to promoting equal opportunities and encourage applications from individuals with disabilities.

What we provide

  • Competitive salary with additional bonuses for holidays and vacations
  • Up to 30 days of paid leave annually
  • Coverage for travel expenses
  • Opportunities for professional development through e-learning
  • A comprehensive range of employee benefits

Responsibilities

  • Reviewing batch documentation for compliance
  • Overseeing the execution of chemical and physical quality assessments according to established specifications
  • Validating and verifying analytical methodologies
  • Developing forms, data collection sheets, and standard operating procedures (SOPs)
  • Documenting, analyzing, and archiving test outcomes
  • Preparing Out of Specification (OOS) and deviation reports
  • Maintaining and calibrating measurement instruments and addressing minor issues
  • Conducting tasks related to equipment qualification and software validation
  • Implementing GMP-compliant practices within the laboratory environment

Candidate Profile

  • Completed technical or scientific vocational training, with relevant further qualifications in pharmaceutical or chemical engineering
  • Strong understanding of general GMP standards
  • Relevant professional experience in Batch Record Review is preferred
  • Familiarity with drug analysis and applicable GMP regulations
  • Proficient in German and possess good written and spoken English skills
  • Ability to collaborate effectively within a team and work independently in a structured manner
  • Demonstrated initiative, assertiveness, and a strong sense of responsibility

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