_qs_operativ

Quality assurance – operational (Batch Release Unit)

Tasks:

  • Ensuring GMP and regulatory compliance of manufactured products
  • Professional maintenance of commissioned contract manufacturers/ laboratories: qualification, establishment and monitoring
  • Assistance with the creation, handling and ongoing updating of related contracts
  • Implementation, documentation and checking of the results of audits
  • Technical pharmaceutical support (instructions, specifications, complaints)
  • Cross-departmental project work regarding the supply chain management of products, particularly for new launches and changes
  • Planning, implementation and assessment of the Batch Record Reviews when preparing the approval for transport of medicinal product batches by the qualified person
  • Batch release for transport and shipping by the QP
  • Preparation of the approval of written instructions (master regulations)
  • Creation and evaluation of product quality reviews
  • Effective and efficient organisation of the batch documentation cycle  
  • Assistance with the company-wide inspection regarding GMP compliance