QC Manager stands for Quality Control Manager - Martin, United States - Quantum Ventures
Description
Head of QC for a pharmaceutical company in Berlin
My client is a globally operating and research-based pharmaceutical company in Berlin, specializing in the development of medicines. Due to a vacancy, they are looking for a Head of Quality Control in the analytical department. You will report to the Head of Quality Unit and be responsible for managing 9 employees.
Your responsibilities:
You will be responsible for leading the QC department and ensuring GMP compliance in the QC area according to EU GMP guidelines and AMWHV. This includes overseeing an experienced laboratory team for the testing and release of raw materials, intermediates, and finished products of medicines and dietary supplements. You will also be responsible for creating PQRs, conducting manufacturer and supplier qualifications, and performing audits. Additionally, you will be in charge of creating, approving, and updating specifications, testing methods, and work instructions. You will also oversee stability studies, have regulatory responsibility for numerous registered and approved medicines, and ensure their continued compliance. You will participate in GMP inspections by authorities, customers, and self-inspections, and collaborate with Quality Assurance, Production, and Management. You will also be involved in the development and implementation of new products. After a training period, you will take on the role of Qualified Person according to § 14 and 15,1 AMG.
Your profile:
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