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QA Operations Expert

vor 2 Monaten

Langkampfen, Österreich Novartis Pharma GmbH Vollzeit
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Novartis Pharma GmbH. As a key member of our QA Medical Device team, you will play a critical role in supporting the commercialization of new medical devices to global markets.

Key Responsibilities:
  • Oversee all production and testing activities to ensure compliance with current Good Manufacturing Practices (cGMP), data integrity, and eCompliance.
  • Support exception investigations and provide expert guidance on quality-related matters.
  • Review and approve production, quality control, and assurance records to ensure accuracy and compliance.
  • Manage and review Master Batch Records (MBRs) to ensure quality and regulatory compliance.
  • Support operational excellence improvement projects to drive efficiency and quality improvements.
  • Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.
  • Manage the distribution of marketing samples, as required.
  • Oversee third-party management of device component and primary packaging material suppliers to ensure quality and regulatory compliance.
  • Review and approve Design History Files (DHF) and Device Master Records (DMR) documents for commercial medical devices and combination products.
Essential Requirements:
  • University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology, or equivalent.
  • At least 3 years of experience in MS&T, QC, or QA, or the medical device industry.
  • Experience in operations management and execution, with a focus on quality and regulatory compliance.
  • Strong negotiation and global collaboration skills, with the ability to work in a fast-paced, dynamic environment.
  • Fluent knowledge of English language (written and spoken), with German language skills an advantage.
  • Ability to operate in a global matrix environment, with a focus on quality and regulatory compliance.
Why Novartis?

At Novartis, our purpose is to reimagine medicine to improve and extend people's lives. We are committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.

We offer a competitive salary, attractive incentive program, modern company pension scheme, childcare facilities, learning and development opportunities, and worldwide career possibilities within the Novartis group.

We are committed to diversity and inclusion, and we strive to create a workplace that is welcoming and inclusive for all employees. If you require adjustments during the recruitment process, please let us know.