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Quality Assurance Specialist

vor 2 Monaten


Wien, Wien, Österreich Takeda Pharmaceutical Vollzeit
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Takeda Pharmaceutical. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and processes.

Key Responsibilities
  • Administer electronic document management and training systems, ensuring seamless operations and compliance.
  • Maintain the local Quality Management System (QMS), including coordination of gap assessments and process improvements.
  • Develop and maintain local Standard Operating Procedures (SOPs) and quality-related documents.
  • Manage and support local deviations and Corrective Action Preventive Action (CAPA) processes.
  • Conduct quality surveillance, engaging with customers on returns, market actions, complaints, inquiries, and customer qualification.
  • Participate in internal and external audits, ensuring compliance with regulatory requirements.
  • Contribute to the preparation of monthly quality reporting, providing insights and recommendations for process improvements.
  • Support health authority communications on product quality issues, ensuring timely and effective resolution.
  • Embody enterprise thinking, identifying innovative solutions to serve patients, build reputation, and trust.
  • Participate in local and global projects, as assigned by the Line Manager.
Requirements
  • Bachelor or Master's degree in a scientific discipline or applicable health sciences field (biotech, pharma, chemistry, or biology).
  • Experience in pharmaceutical companies, with exposure to audits and regulatory compliance.
  • Fluency in spoken and written German and English.
  • Strong communication and organization skills, with the ability to build authentic relationships and work collaboratively as a team.
  • A commitment to lifelong learning, with a focus on developing a growth mindset and taking ownership of personal development.
About Takeda

Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants.

What We Offer
  • A competitive remuneration package, including a minimum salary of € 3,307.50 gross per month.
  • A family-friendly company environment, with support for parental leave, a bilingual kindergarten, and flexible work arrangements.
  • Comprehensive training programs, including in-house job rotation and development opportunities.
  • A comprehensive benefits package, including medical checkups, free vaccination programs, and access to a fitness center.