Quality Assurance Engineer
vor 4 Wochen
Job Title: Quality Assurance Engineer
Location: Germany
Job Type: Freelance Contract
Experience: 5+ Years
We are seeking an experienced Quality Assurance Engineer to join our network and work on innovative projects across Germany's pharmaceutical, biotechnology, and medical device sectors. As a Quality Assurance Engineer, you will be responsible for ensuring high system availability, qualifying and maintaining measuring and testing equipment, and leading qualification activities to ensure compliance with industry standards.
Key Responsibilities:
- System Availability and Maintenance:
- Monitor and maintain system availability to ensure high uptime.
- Qualify and maintain measuring and testing equipment to ensure compliance with 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.
Requirements:
- 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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