Quality Assurance Expert - Sterile Manufacturing (all genders)

Overview

Your Role

As a member of the Site Quality Darmstadt Development team, you will be responsible as Quality Assurance Expert to support the go-live and routine manufacturing in the Technical Development Center at Darmstadt site for parenteral products intended for clinical studies.

In this role you will oversee all manufacturing relevant GMP processes, review and approve the relevant SOPs, perform batch record review including aseptic process validation runs and prepare the product batch documentation for the release step by QP, act as shop floor QA in the plant and be involved in deviation and change control management.

You support the implementation of new parenteral products in the Technical Development Center overseeing local quality requirements.

Further responsibilities include assurance of compliance of processes and products with regulatory requirements and quality standards, including communication with internal and global interfaces in Healthcare Quality.

It will be part of your duties to support site related audits and inspections by competent authorities as well as self-inspections on site.

Responsibilities

• Master in Biology, Chemistry other Scientific discipline or adequate professional experience or Approbation as pharmacist
• 3+ years of operating experience in pharmaceutical GMP manufacturing of parenteral products
• 2+ years of experience in pharmaceutical development environment
• Experience in monitoring and evaluation of sterile manufacturing processes
• Know-how of electronic document management systems (Mango, Trackwise, etc.) as well as electronic manufacturing execution systems (MES/ERP)
• Experience with methods and concepts ofpharmaceutical quality systems
• Knowledge of governmental regulatory guidelines and regulations relating to the manufacturing of pharmaceuticals
• Fluent in German and English
• Strong ability to communicate even in challenging situations, team oriented, outcome-oriented personality

Department and other details

Department: HC-GM-QHCC QA I Product Quality DS/DP

Job evaluation: AT-level 3 (Expert)