Manages the quality assurance (ex. supplier and product qualification, complaint management, customer query response) and quality control activities (CoA review and approval, product creation approval etc.) related to assigned products, on daily basis. The aim is ensuring compliance to relevant regulations and customer requirements, within EMEA, including REACH requirements follow up and enforcing compliance. Product Stewardship included.
Quality system management tasks are part of duties, such as contribution to SOP creation and training.
The position requires autonomous mode of working, with strong organisational and communication skills both internal to the company and external (customers).
• Scientific background in Biology, Chemistry, Biochemistry or Biotechnology
• At least 5 years (5-10) relevant experience in working with Quality Management Systems, Quality Assurance / Quality Control
• Product Stewardship experience (regulatory support, REACH regulation knowledge etc.)
• Knowledge of API GMP guidelines and practices, ISO 9001:2015 are required.
• Fluent English required, German is a significant plus.
