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SOSobi

QA Analytical Specialist(m/w/x)

Basel
Vollzeitmit HomeofficeSenior

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.

Anforderungen

  • 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

Aufgaben

  • 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

Berufserfahrung

  • 5 Jahre

Ausbildung

  • Bachelor-Abschluss

Sprachen

  • Englischverhandlungssicher

Benefits

Attraktive Vergütung

  • Competitive compensation

Familienfreundlichkeit

  • Work/life balance

Lockere Unternehmenskultur

  • Collaborative and team-oriented environment

Karriere- und Weiterentwicklung

  • Professional growth opportunities

Sonstige Vorteile

  • Diversity and Inclusion
  • Competitive benefits package

Sinnstiftende Arbeit

  • Positive impact for rare disease patients
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sobi erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.

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