Production Compliance Manager (f/m/d)

at  Aqvida Gmbh

PRODUCTION COMPLIANCE MANAGER (F/M/D)

[Diese Stellenausschreibung ist nur auf Englisch verfasst, da für diese Position fließende Englischkenntnisse unbedingt erforderlich sind.]
AqVida is a pharmaceutical company specializing in the development, registration, manufacturing, and distribution of oncology products. Our portfolio includes key generics used in the treatment of the most common cancer types. While our customers are located globally, we have two sites in Northern Germany: since 2005, our headquarters in Hamburg, and our state-of-the-art production facility in Dassow, Mecklenburg-Vorpommern, inaugurated in 2016.
Preferably for our office in the heart of Hamburg, we are looking for a dedicated “Production Compliance Manager (f/m/d)” starting in December 2024. The role is responsible for maintaining and updating our manufacturing instructions (Master Batch Records, MBR) and ensuring compliance with GMP guidelines.

• Maintenance and updating of the Master Batch Records, Batch Records, and Quality Assurance Agreements (QAA) in accordance with market authorizations and GMP
• Supplier qualification: Managing approved supplier lists, audit coordination, and preparing audit reports
• Change control communication
• Management and maintenance of stability data
• Close collaboration with various internal and external stakeholders to ensure quality and compliance in production