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LOLonza

QA Expert, Manufacturing Release(m/w/x)

Stein (AR)
Part-timeOn-siteExperienced

Batch release for aseptic drug products, including SOPs and change control. GMP compliance and deviation management experience required. Relocation assistance, agile career path.

Requirements

  • BSc, MSc, or PhD in Natural Sciences or Pharmaceutical Sciences
  • Experience in sterile drug product or substance manufacturing in GMP environment
  • Experience in deviation and change management
  • Work experience in QA is advantageous
  • Hands-on personality, open approach to business partners, excellent influencing and negotiation skills
  • Fluency in English
  • German language skills are advantageous

Tasks

  • Perform batch release for aseptic manufactured drug products
  • Write, review, and approve procedures, SOPs, risk assessments, and gap assessments
  • Ensure GMP compliance in electronic systems and paper-based documents
  • Approve change requests, deviations, and CAPAs related to product and process
  • Promote and enforce compliance with internal and external quality and safety guidelines
  • Ensure required knowledge and skills, identify competency gaps, and develop solutions
  • Lead development and evaluation of new tools, processes, and quality initiatives
  • Be present at the manufacturing line to support manufacturing activities
  • Support projects and maintain Sterile Production Stein line functions in GMP compliance

Work Experience

  • approx. 1 - 4 years

Education

  • Doctoral / PhD

Languages

  • EnglishFluent
  • GermanBasic

Benefits

Other Benefits

  • Relocation assistance

Career Advancement

  • Agile career

Informal Culture

  • Dynamic work culture

Purpose-Driven Work

  • Inclusive and ethical workplace

Bonuses & Incentives

  • Compensation programs for high performance

Corporate Discounts

  • Lifestyle benefits
  • Leisure benefits

Family Support

  • Family benefits
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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