Quality Assurance Manager (m/f/d)

Contract duration: 1 year, with possible extension

Languages: German and English

Responsibilities:

• QA oversight of qualification and validation activities for GMP-relevant plants and systems in drug substance and/or drug product manufacturing
• QA Oversight of CSV Systems
• Support the implementation of data integrity requirements.
• Review and approval of GMP documents (e.g. qualification plans, reports, change and deviation management, CAPAs, SOPs, risk analyses).
• Perform in-depth root cause analysis to solve complex problems.
• Driving optimization and improvement activities within IMP Quality
• Collaborate with stakeholders and contribute to the achievement of common goals
• Representing the area of responsibility during inspections by health authorities and internal audits.
• Supporting end-to-end cGMP activities and maintaining the right to operate

Requirements:

• Fluent in German is mandatory
• Academic degree in engineering, chemistry, life science, pharmacy or comparable
• At least 5 years of professional experience in the pharmaceutical industry, including at least 2 years in the field of Quality Assurance
• Min. 3 years of experience in plant qualification/validation
• Understanding of current data integrity (DI) requirements
• Knowledge of global quality and GMP requirements
• Proven success in inspections by health authorities and internal GMP audits
• Strong team player with excellent communication and influence skills