Quality Engineering Compliance Manager (M/W/D)

Tasks

• Review and Approve URSes, Quality Risk Assessments and Design Qualification for a new Downstream Center for the Manufacture of chemically synthesized Peptides, containing major equipment such as HPLCs, Freeze Drier, Spray Drier, Cleanrooms Grade D and C, Utilities and process gases
• Provide Input to URSes, Design Concepts and Documents from a Quality perspective and ensure Design meets intended purpose
• Provide Input to Project Deviations and Project Change Controls as Quality Reviewer/Approver
• Collaborate with cross-functional teams to ensure compliance with quality assurance standards meeting regulators and health authorities’ expectations
• Ensure with /support global quality in qualifying Equipment suppliers and service providers

Qualifications

• Extensive experience In Quality Engineering (min 5 years), specifically related to compliance oversight of C&Q and CSV in CAPEX Projects
• Experience in digital validation software ( Kneat)
• Basic understanding of regulatory requirements, engineering standards and industry best practices (EU, PICS, ICH, FDA, ISPE, GAMP)
• Excellent communication and interpersonal skills, strong, proactive “how can I help attitude”
• German and English (business fluent)

Conditions

• Start: ASAP
• Duration: 6 months
• Workload: Full-time
• Location: 4 days onsite (Stein) – 1 day remote