Specialist (m/w/d) Change Control New Assets / GDP - #2108883

YOUR CONTRIBUTION

Join our global quality operations team and grow with exciting challenges. With your passion and expertise and together with our international colleagues, you will contribute to achieving our company goals. As a Specialist in Quality, your responsibilities will include the following tasks:

• Support organizational development by establishing and enhancing supplier management for new assets
• Execution of supplier management, including qualification (review, execute, and approve), auditing, and collaboration on creating/ maintaining of Quality Agreements
• Coordination and support of audits by authorities and customers, monitoring the timely resolution of findings
• Create, negotiate, and maintain of Quality Agreements
• Continuous assurance of up-to-date and compliant documentation for the local regulatory authority (manufacturing and import license, GMP certificate, wholesale license, GDP certificate)
• Create and update department-specific SOPs
  
  

YOUR PROFILE

• Completed scientific Studies in Pharmacy, Chemistry or a related field of studies, PhD is an advantage
• Minimum 3 years of experience in the pharmaceutical industry, ideally within quality assurance
• Knowledge in quality management, auditing, manufacturing, and testing, as well as experience in dealing with regulatory authorities
• Good knowledge of cGMP (EU, FDA) and GDP
• Proficiency in Microsoft Office Suite
• Ideally, qualification as an auditor and good knowledge of SAP ERP
• Teamoriented and motivated organizational talent with the ability to work independently
• Good verbal and written communication skills in German and English
• Willingness to travel
  
  

Your Benefits

• Individual career development in a purposeful job: you improve the quality of life of our patients!
• Hybrid work model that allows a good work-life balance
• Attractive location with good transport links, modern workplaces and a company restaurant
• Global family business with flat hierarchies and an open, respectful corporate culture
• Attractive remuneration with extensive social benefits
• Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike