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SOSobi

QA Analytical Specialist(m/w/x)

Basel
Full-timeWith Home OfficeSenior

Ensuring GMP-compliant methods and data for release and stability testing at a biopharmaceutical company. Strong GMP understanding and quality-minded analytical professional required. Work/life balance, health support.

Requirements

  • Quality-minded analytical professional
  • Enjoyment of cross-functional work
  • Taking ownership
  • Bringing structure to complex scientific work
  • Strong GMP understanding
  • Collaborative mindset
  • Motivation to deliver high-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
  • Deviation investigations
  • Change control
  • Ideally QA supporting QC or QC Coordinator
  • 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

  • Ensure GMP-compliant methods and data for release and stability testing
  • Coordinate and approve deviations, CAPA, and change controls
  • Approve GMP-related analytical activities, including validation and technology transfer
  • Evaluate and ensure quality of CLOs
  • Serve as QA contact for CLOs
  • Approve stability study 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 and provide QA analytical guidance
  • 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

Other Benefits

  • Competitive benefits package

Healthcare & Fitness

  • Health support

Mental Health Support

  • Happiness support
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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