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NONovartis Pharmaceutical Manufacturing GmbH

Senior Quality Assurance Operations Specialist(m/w/x)

Kundl
Full-timeOn-siteSenior
Apply now

Reviewing batch records and assessing analytical results for drug substance manufacturing. Master's degree in Microbiology and GMP experience required. Support for audits and deviation investigations.

Requirements

  • Master's degree in Microbiology
  • Solid experience in pharmaceutical or GMP-regulated environment
  • Experience in quality assurance or quality control preferred
  • Strong knowledge of GMP requirements
  • Results-driven mindset with continuous improvement focus
  • Strong customer focus and communication skills
  • Fluent in German and English
  • Collaboration skills
  • Communication skills
  • Data integrity knowledge
  • Dealing with ambiguity
  • Digital savviness
  • Leadership skills
  • Operational excellence knowledge
  • Problem solving skills
  • Regulatory requirements knowledge

Tasks

  • Review and approve batch manufacturing records
  • Assess analytical results, certificates, and specifications
  • Verify batch documentation and quality records
  • Support audits, inspections, and regulatory interactions
  • Conduct investigations related to deviations, OOS/OOE, and complaints
  • Manage CAPA activities and process changes
  • Prepare and review certificates, reports, and quality lists
  • Coordinate with internal departments and external partners
  • Execute tasks efficiently and GMP-compliantly

Work Experience

  • approx. 4 - 6 years

Education

  • Master's degree

Languages

  • German – Business Fluent
  • English – Business Fluent
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