Quality Assurance Specialist

vor 19 Stunden

Schlieren, Schweiz DINAMIQS Vollzeit

Siegfried DINAMIQS is a Contract Development and Manufacturing Organization (CDMO) based in the BIO-TECHNOPARK Schlieren-Zurich, Switzerland, specializing in the manufacturing of viral vectors for gene therapies.

At DINAMIQS, we offer a comprehensive range of services, including vector design optimization, cutting-edge process development and analytics, as well as manufacturing. With a state-of-the-art R&D facility running and building a new GMP facility, we are dedicated to supporting gene therapy projects with scalable and efficient solutions.

DINAMIQS has become part of Siegfried's global network in 2023 and is now looking to grow its dedicated team of experts by hiring a QA Specialist.

In this role, you will play a crucial part in establishing our new GMP facility. You will be integral to setting up and maintaining a quality management system and develop, implement, and manage quality assurance methods, ensuring compliance with regulatory requirements and internal standards.

If you are highly motivated, detail-oriented, and passionate about driving quality excellence in a new production environment, you are the person we are looking for.

Your role

  • Assist in implementing quality systems, qualifying the facility, and planning QA-related workflows to support GMP facility establishment
  • Manage the documentation control system, ensuring all SOPs, batch records, and other quality documents are up-to-date and compliant
  • Participate in internal and external audits, preparing the facility for regulatory inspections
  • Support managing supplier qualification and quality agreements
  • Act as the primary QA contact in the GMP facility including on the shop floor
  • Review and approve batch records, deviation reports, and other quality documents
  • Conduct root cause analysis and manage CAPA processes
  • Actively contribute to a culture of quality and continuous improvement throughout the organization

Your profile

  • B.Sc or M.Sc. in Biotechnology, Virology, Molecular Biology,
  • At least 5 years of experience in a GMP-regulated biopharmaceutical environment, with at least 2 years in QA.
  • In-depth knowledge of viral vector production processes and related quality control techniques.
  • Strong understanding of regulatory requirements (e.g., EMA, FDA) and industry guidelines (GMP).
  • Excellent analytical and problem-solving skills.
  • Exceptional communication and interpersonal skills.
  • Proficiency with QMS software and quality management tools.
  • Fluency in English

What you can expect

  • A unique and amazing work experience, being part of one of the most dynamic, diverse and inclusive CDMOs in the industry
  • Competitive and attractive compensation
  • 5 weeks holidays and flexible working hours make it possible to combine family, leisure time and career
  • Impactful Work: Make a significant difference through innovative gene therapy projects
  • Learning Opportunities: Develop diverse skills in a dynamic environment
  • Fast-Paced Environment: See results quickly and enjoy creative freedom in defining your operating model and go to market strategy

Are you interested in joining a motivated team with an inclusive and collaborative culture? Then take the next step and send us your application via LinkedIn.

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