Quality Assurance Manager (m/f/d) Pharmaceuticals

Your area of responsibility

• QA contact for project teams in Global QA R&D Lab activities
• Review and approval of quality-relevant documents according to development progress
• Collaboration in the development and ongoing maintenance of QM systems within Global R&D and support for group-wide harmonisation
• Monitoring of compliance with relevant legislation and guidelines for the development of medical products
• Support of the supervised functions in the creation, revision and review of SOPs
• Planning, preparation and implementation of self-inspections (internal audits) in the area of Laboratory activities in Global R&D as well as Creation of audit reports and suggestions for resolving identified issues.
• Planning, preparation and execution of external audits for the Laboratory activities and Global R&D related to suppliers in the context of medical product development as well as Creation of audit reports and suggestions for resolving identified issues
• Monitoring the development of directives and standards and norms at national and international level and transfer of findings to the relevant professional function
• Preparation and accompaniment as well as support of official inspections or the Notified Body of the client
• Organization and implementation of training courses
• Management of deviations, CAPA processes and changes (change control) in the area of Laboratory activities
• Cooperation in ensuring supplier qualification

The next level starts here

• A wide range of training courses
• Exciting and varied projects with innovative companies
• Professional and personal development opportunities
• Attractive offices and a workplace with modern hardware
• Permanent employment contract
• Employee savings scheme

Impress us with your qualifications

• Completed studies in natural sciences
• Several years of professional experience in the pharmaceutical or medical product industry
• 2 or more years of experience in quality assurance in the development of medicines or medical products
• Fluent English (written and verbal) is mandatory
• Comprehensive knowledge of the regulatory requirements for medical products
• Proficiency in MS Word and knowledge of ISO 13485
• Knowledge in EU GMP and Laboratory Regulatory requirements is a plus
• High motivation and willingness to learn new areas of work as well as to travel national and international

Looking for the next challenge? Then we should definitely get to know each other! We look forward to receiving your application - online quoting reference FE27-77412-F to Ms. Tamara Mohr. Let us get to the next level together and take technology forward!