Specialist Batch Record Review - Pharma | Specialist Batch Record Review - Pharma (m/w/d)
FERCHAU GmbH Niederlassung Ulm
Job Summary
As a Specialist Batch Record Review in the pharmaceutical and life sciences sector, you will play a crucial role in ensuring the quality and compliance of biopharmaceutical products. Your daily tasks will involve meticulously reviewing batch manufacturing documentation for active ingredients, including in-process testing of biopharmaceutical products, all in strict adherence to GMP guidelines and internal standard operating procedures (SOPs). You will be responsible for identifying and clarifying batch-related deviations, initiating deviation creation where necessary, and documenting all observations. This position requires strong attention to detail, a proactive approach to problem-solving, and excellent communication skills to interact with various departments and compliance officers. The role offers an attractive compensation package and opportunities for professional growth within a supportive team environment, contributing to innovative solutions in the pharmaceutical industry.
Required Skills
Education
Completed training as a Biology or Chemistry Laboratory Assistant (CTA, BTA) or other relevant education, ideally with knowledge in biopharmaceutical active ingredient manufacturing
Experience
- Experience in Batch Record Review is desirable
- GMP experience and understanding of biopharmaceutical production processes are beneficial
Languages
Additional
- Not specified
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