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TEten23 health

QA for QC Expert(m/w/x)

Basel
Full-time, Part-timeOn-siteExperienced

Quality oversight for analytical method validation and equipment CQV for injectable treatments at a pharma/biotech partner. Proven QA experience in GMP-regulated drug product manufacturing or testing required. Annual bonus.

Requirements

  • Master's degree in science (Biology, Microbiology, Pharmacy, or similar)
  • Proven QA experience in GMP-regulated drug product manufacturing or testing
  • Strong understanding of QC operations, analytical methods, data integrity principles
  • Experience in microbiology (plus)
  • Fluency in spoken and written English
  • Independent and efficient team player
  • Thrives in interdisciplinary collaboration
  • High degree of flexibility in problem-solving
  • Proactive approach to contributing ideas
  • Strong willingness to take on responsibilities

Tasks

  • Lead quality oversight for analytical method validation.
  • Lead quality oversight for equipment CQV.
  • Manage equipment lifecycle.
  • Review and approve GMP documentation.
  • Review and approve material specifications.
  • Review and approve analytical records.
  • Review and approve QC results.
  • Review and approve CoA/TSE/BSE statements.
  • Perform regular GMP walks.
  • Provide on-floor oversight for sampling.
  • Provide on-floor oversight for transport.
  • Provide on-floor oversight for general QC operations.
  • Manage material labels.
  • Manage ERP material status (excluding Drug Product).
  • Handle the release of materials.
  • Administer MODA system.
  • Oversee sampling plans.
  • Oversee APS quality requirements.
  • Manage Deviations within QC.
  • Manage CAPAs within QC.
  • Manage Change Controls within QC.
  • Support laboratory investigations.

Work Experience

  • 2 - 5 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent

Benefits

Retirement Plans

  • Competitive pension fund plan

Bonuses & Incentives

  • Annual bonus

Career Advancement

  • Career development opportunity

Flexible Working

  • Flexible working arrangements

Informal Culture

  • Open culture
  • Diverse workforce

Mentorship & Coaching

  • Opportunity to learn from experienced employees

Learning & Development

  • Learning and self-developing culture
  • Training options
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ten23 health 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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