Quality Assurance Engineer – Batch Record Review | Ingenieur (m/w/d) Qualitätssicherung – Batch Record Review (1604)
Brüggen Engineering GmbH
Job Summary
As a Quality Assurance Engineer specializing in Batch Record Review, you will play a pivotal role in ensuring pharmaceutical production standards meet strict GMP requirements. Your daily responsibilities include the meticulous review and release of manufacturing instructions and documentation, ensuring all batch records are accurate and compliant. You will manage batch timelines, prepare for GMP audits, and contribute to the optimization of production processes through data analysis. A significant part of the role involves maintaining Standard Operating Procedures (SOPs) and training staff on quality standards. This position is particularly attractive for those looking to influence digital transformation in the industry, as you will assist in implementing new Electronic Batch Record (EBR) systems. Working within a dynamic team at BRÜGGEN ENGINEERING, you will have a direct impact on product safety and process efficiency in the parenteral manufacturing sector.
Required Skills
Education
University degree in Biotechnology or a comparable field of study.
Experience
- Professional experience in pharmaceutical production, specifically in parenteral manufacturing
- Demonstrated experience in pharmaceutical documentation and quality control
- Experience working within GMP-regulated environments
- Experience with electronic systems such as MES and SAP
Languages
Additional
- Must be able to work full-time in a permanent (unbefristet) position. Requires the ability to conduct internal employee training and participate in regulatory audit processes.
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