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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. Professional fluency in both German and English required. Flexible working schedule with pension scheme.

Requirements

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

Benefits

Competitive Pay

  • •Competitive salary

Bonuses & Incentives

  • •Annual bonus

Flexible Working

  • •Flexible working schedule
  • •Work from home possibility

Retirement Plans

  • •Pension scheme

Other Benefits

  • •Employee Recognition Scheme

Healthcare & Fitness

  • •Wellbeing health promotion program

Job Security

  • •Employment at Top SI Employer

Learning & Development

  • •Unlimited learning and development
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