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SOSobi

QA Analytical Specialist(m/w/x)

Basel
Full-timeWith Home OfficeSenior

Approving GMP analytical activities, including validation and technology transfer, for rare disease biopharmaceuticals. Strong GMP understanding and ownership of complex scientific work required. 4-day work week, company car for private use.

Requirements

  • Quality-minded analytical professional
  • Cross-functional collaboration
  • Ownership of complex scientific work
  • Structure to complex scientific work
  • Strong GMP understanding
  • Collaborative mindset
  • Motivation to deliver quality medicines
  • University degree in Chemistry, Biology, Biotechnology, Pharmaceutical Science, or similar
  • 5+ years GMP analytical work in pharma/biotech
  • Analytical method development and validation
  • Product specifications experience
  • Deviation investigations experience
  • Change control experience
  • QA supporting QC or QC Coordinator experience
  • Broad knowledge of analytical chemistry and bioassays
  • Clear and compliant documentation practices
  • Professional proficiency in English, written and spoken
  • Living Sobi CARE values
  • Ability to work independently
  • Ability to take initiative
  • Ability to make sound quality decisions
  • Strong communication skills
  • Collaborative, team-oriented approach
  • Structured mindset
  • Attention to detail
  • Commitment to continuous improvement
  • English language proficiency

Tasks

  • Coordinate and approve deviations, CAPA, and change controls
  • Approve GMP-related analytical activities, including validation and technology transfer
  • Evaluate and approve CLO performance
  • Serve as QA contact for CLOs
  • Provide QA for stability studies, approving plans and protocols
  • Review and approve extension of expiry dates for critical analytical materials
  • Review and approve product specifications
  • Support Global Regulatory Affairs / CMC in analytical quality issues
  • Represent Global Quality, providing QA analytical guidance for projects
  • Manage Quality Technical Agreements with CLOs
  • Author, review, and approve SOPs and related documentation

Work Experience

  • 5 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent

Benefits

Competitive Pay

  • Competitive compensation

Family Support

  • Work/life balance

Informal Culture

  • Collaborative and team-oriented environment

Career Advancement

  • Professional growth opportunities

Other Benefits

  • Diversity and Inclusion
  • Competitive benefits package

Purpose-Driven Work

  • Positive impact for rare disease patients
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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