Senior Quality Assurance Engineer

Vor 3 Tagen

Hannover, Niedersachsen, Deutschland Optimus Life Sciences Vollzeit

Job Overview:

We are seeking a highly skilled Quality Assurance Engineer to join our team at Optimus Life Sciences. As a key member of our team, you will be responsible for ensuring the highest level of quality in our projects.

Key Responsibilities:

  • System Availability and Maintenance:
  • Monitor and maintain system availability to ensure seamless operations.
  • Qualify and maintain measuring and testing equipment to meet industry standards.

Change Control and Qualification Activities:

  • Initiate and manage change control procedures in collaboration with supervisors.
  • Lead qualification activities to ensure all processes meet regulatory standards.

Project Management and Collaboration:

  • Participate in technical projects, modifications, and system improvements.
  • Lead or assist in managing change control procedures and ensure seamless collaboration across teams.

Documentation and Compliance:

  • Create and manage qualification documents such as URS, DQ, IQ, OQ, PQ, ensuring compliance with EC guidelines, ISO, and DIN standards.
  • Plan, execute, and document GMP-compliant requalification activities.

Qualification of Equipment and Systems:

  • Oversee the qualification of existing devices and systems as part of functional testing.
  • Provide support during the construction and commissioning of new systems, with a focus on qualification and technical aspects.

Required Qualifications and Skills:

Education:

  • Engineering degree with a focus on building equipment/supply engineering, process engineering, mechanical engineering, or a related natural science field.

Technical Expertise:

  • Strong understanding of GMP, quality, and regulatory standards.
  • Technical knowledge of aseptic filling, manufacturing processes, and automation, with a focus on data integrity.

Project Management:

  • Experience in project management, with proven participation in technical projects.
  • Ability to manage multiple tasks while maintaining a structured and independent working style.

Technical Skills:

  • Proficient in using common MS Office applications.
  • Experience in qualification document creation and compliance with applicable standards (EC guidelines, ISO, DIN).

Language and Travel:

  • Fluent in both written and spoken German and English.
  • Willingness to travel occasionally for business purposes.

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