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LOLonza

Quality Assurance Expert Analytics, Drug Product Services(m/w/x)

Basel
Full-timeOn-siteSenior

Reviewing and approving analytical methods and validation protocols for biological drug products. Master's degree and 5-6 years of cGMP experience required. Ethical workplace, performance-based compensation programs.

Requirements

  • Master's degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
  • Minimum 5-6 years experience in Quality Assurance in pharmaceutical industries and cGMP
  • Good working knowledge of EU and US GMP regulations
  • Sound knowledge in testing of biological drug products
  • Excellent communication and decision-making skills
  • Ability to provide solutions for complex challenges
  • Ability to work independently
  • Team player
  • Detailed oriented
  • Precise
  • Pro-active
  • Well organized
  • Excellent knowledge of written and spoken English

Tasks

  • Establish and maintain Quality Management System
  • Ensure staff qualification and GMP adherence
  • Review and approve analytical methods
  • Review and approve qualification protocols
  • Review and approve validation protocols
  • Review and approve transfer protocols
  • Review and approve analytical reports
  • Review and approve analytical SOPs
  • Supervise GMP compliance activities
  • Execute GMP compliance activities
  • Approve deviations for Analytics/Quality Control
  • Approve deviations for OOS investigations
  • Act as first contact for compliance issues
  • Approve specifications in LIMS
  • Counsel groups on projects
  • Counsel groups on GMP aspects

Work Experience

  • 5 - 6 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent

Benefits

Purpose-Driven Work

  • Inclusive and ethical workplace

Bonuses & Incentives

  • Compensation programs that recognize high performance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza 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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