Quality Assurance Associate; Batch Release

Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech and cosmetics industries. The company offers a comprehensive portfolio of pharmaceutical packaging, drug delivery systems, medical devices and digital solutions. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With around 13,600 employees and over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets.

Core Objective:
Ensure process-compliant batch release for downstream process steps

• Independent inspection of batch documentation with all necessary individual tasks (e.g. manufacturing records, internal complaints, inspection orders, etc)
• Ensuring deviation management (preparation of internal complaints)
• Execution of batch releases (e.g. for semi-finished goods, goods receipt)
• Preparation of the necessary documentation according to internal specifications (control charts, evaluations, etc)
• Carrying out pallet release and special measurements according to specifications
• Procurement of certificates and organization of inspection lots according to instructions

• Knowledge of quality management processes
• Knowledge of Batch Release procedure
• GMP/GDP
• Experience with deadline monitoring
• Experience with quality documentation and Device History Record (DHR)
• Good knowledge of FDA and ISO regulations
• Knowledge acquired as part of a 3-year vocational training program and expanded through 2 years of professional experience in the field of quality assurance.