Quality Assurance Manager (m/d/f) 80%

Job Description

• Review and approval of SOPs, protocols, reports, Certificate of Analysis and other quality documents
• Support quality investigation of deviations and Out of Specification (OOS)
• Maintenance, recording and processing of corrective and preventive measures (CAPA)
• Organization and management of customer audits, and inspections
• Apply and interpret audit and compliance requirements
• Act as QA point of contact for customers
• Support for GMP training
• System Administration of Quality Management Software

Requirements

• Scientific education (Master degree) in analytical chemistry / biochemistry / life science
• Multi-year, industrial work experience of 7 years minimum in the analytical-pharmaceutical environment preferably experience in QA
• Strong problem-solving skills to meet business objectives
• Excellent interpersonal skills and teamwork spirit
• Ability to collaborate in a dynamic, cross-functional matrix environment
• Broad knowledge and proven experience of the regulatory framework in the GMP environment (ICH, FDA, USP, Ph. Eur.)
• Solid background in data integrity and computerized systems risk assessment and project support
• Experience as system administrator or deeper IT knowledge is an asset
• Fluency in English and wiliness to learn German is required

Benefits

• a well-structured onboarding program
• intensive training in the beginning
• the possibility for further development
• flexible working time models
• 40 hours week
• at least 28.5 vacation days per year (depending on your age)
• commuter contribution for using public transport
• staff restaurant