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NONovartis Radiopharmaceuticals GmbH

Quality Assurance Officer Operations(m/w/x)

Halle (Saale)
Full-timeWith Home OfficeExperienced
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Review and approval of batch release records, CAPAs, and OOX investigations for API manufacturing. Fluent German and English with 3+ years GxP pharmaceutical experience required. Flexible working schedule and employee recognition scheme.

Requirements

  • Bachelors' Degree in Life Sciences, Chemistry or related degree
  • 3+ years GxP (Bio)pharmaceutical or API manufacturing experience
  • 2+ years Quality Assurance experience
  • QA or QC experience with environmental monitoring
  • Fluent written and spoken English and German

Tasks

  • Manage quality aspects and projects within your area
  • Ensure GxP conformity and Novartis Quality Management System compliance
  • Review and approve test records for batch release
  • Review and approve SOPs, CAPAs, and deviations
  • Manage OOX investigations and Quality Risk Assessments
  • Review and approve Quality Plans, protocols, and change controls
  • Provide shop floor oversight and QA compliance guidance
  • Collaborate with cross-functional teams on quality improvement initiatives
  • Optimize processes to enhance manufacturing efficiency
  • Assist with regulatory inspection preparedness and execution
  • Perform tasks to maintain site cGMP compliance
  • Provide cGMP training to quality and operational teams
  • Support and review exception investigations
  • Review and approve production, QC, and AS&T records
  • Support OpEx improvement projects
  • Execute batch release in compliance with registration

Work Experience

3 years

Education

Bachelor's degree

Languages

English – Business FluentGerman – Business Fluent

Tools & Technologies

GxPAPI manufacturing operationsEnvironmental monitoring

Benefits

Flexible Working

  • •Flexible working schedule
  • •Work from home

Bonuses & Incentives

  • •Annual bonus

Retirement Plans

  • •Pension scheme

Other Benefits

  • •Employee Recognition Scheme

Healthcare & Fitness

  • •Wellbeing health promotion program

Job Security

  • •Top SI Employer employment

Learning & Development

  • •Unlimited learning and development
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Radiopharmaceuticals GmbH 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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