Aktuelle Jobs im Zusammenhang mit Senior Quality Assurance Engineer | North Germany | Freelance - Hannover, Niedersachsen - Optimus Life Sciences
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Senior Quality Assurance Engineer | North Germany | Freelance
vor 2 Monaten
Optimus Life Sciences is seeking a highly skilled Senior Quality Assurance Engineer to contribute to the success of our innovative projects in Germany's pharmaceutical, biotechnology, and medical device sectors.
Key Responsibilities:- Ensure high system availability through continuous monitoring and proactive measures, guaranteeing seamless operations and minimizing downtime.
- Qualify and maintain measuring and testing equipment, ensuring compliance with industry standards and regulations, such as EC guidelines, ISO, and DIN.
- Initiate and manage change control procedures in collaboration with supervisors, ensuring all processes meet regulatory standards and company policies.
- Lead qualification activities as required, ensuring all processes meet regulatory standards and company policies.
- Participate in technical projects, modifications, and system improvements, driving innovation and efficiency within the organization.
- Lead or assist in managing change control procedures and ensure seamless collaboration across teams, fostering a culture of open communication and cooperation.
- 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, ensuring all processes meet regulatory standards and company policies.
- Oversee the qualification of existing devices and systems as part of functional testing, ensuring all processes meet regulatory standards and company policies.
- Provide support during the construction and commissioning of new systems, with a focus on qualification and technical aspects, ensuring all processes meet regulatory standards and company policies.
- Engineering degree with a focus on building equipment/supply engineering, process engineering, mechanical engineering, or a related natural science field.
- Strong understanding of GMP, quality, and regulatory standards, with a focus on data integrity and compliance.
- Technical knowledge of aseptic filling, manufacturing processes, and automation, with a focus on data integrity and compliance.
- Experience in project management, with proven participation in technical projects, driving innovation and efficiency within the organization.
- Ability to manage multiple tasks while maintaining a structured and independent working style, with a focus on quality and compliance.
- Proficient in using common MS Office applications, with a focus on data analysis and reporting.
- Experience in qualification document creation and compliance with applicable standards (EC guidelines, ISO, DIN), with a focus on quality and compliance.
- Fluent in both written and spoken German and English, with a focus on clear communication and collaboration.
- Willingness to travel occasionally for business purposes, with a focus on collaboration and teamwork.
