Senior Quality Assurance Engineer
vor 4 Wochen
Location: Germany (On-Site Project)
Type: Freelance Contract
Experience Required: 5+ Years
We are seeking a highly skilled Senior Quality Assurance Engineer to join our team and work on innovative projects across Germany's pharmaceutical, biotechnology, and medical device sectors.
Key Responsibilities:
- System Availability and Maintenance:
- Ensure high system availability through continuous monitoring and proactive measures.
- Qualify and maintain measuring and testing equipment, ensuring compliance with industry standards.
Change Control and Qualification Activities:
- Initiate and manage change control procedures in collaboration with supervisors.
- Lead qualification activities as required, ensuring 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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