Quality Assistant, Hygiene Management | Quality Assistant Hygiene Management | M/W/D - Referenz 001056
consult16 GmbH
Job Summary
This Quality Assistant role supports hygiene and quality assurance for an international pharmaceutical company, initially on a 12-month fixed-term contract. The core responsibilities involve the GMP-compliant execution, documentation, and evaluation of hygiene and cleanroom monitoring, including both routine and specialized checks. Key daily tasks include coordinating external service providers for cleaning and microbiological testing, planning and delivering essential hygiene and GMP training for internal and external staff, and assisting with the collection and analysis of quality-relevant KPIs and trending reports. A crucial part of the job is the processing of deviations and the implementation of resulting Corrective and Preventive Actions (CAPAs). Successful candidates must have a completed scientific or technical education and several years of professional experience in a GMP-regulated environment, coupled with expertise in cleanroom technology and regulatory standards like EU GMP Annex I. The position offers an opportunity to drive process optimization and maintain high regulatory compliance standards.
Required Skills
Education
Completed scientific-technical education
Experience
- Several years of professional experience in a GMP-regulated environment (Quality Assurance, Quality Control, or Production)
- Fundamental knowledge of hygiene processes, cleanroom technology, and hygiene monitoring
Languages
Additional
- Position is initially limited to 12 months (fixed-term contract). Workplace is Biberach. Hybrid work model available, but significant on-site presence is required for training and important appointments. Travel and accommodation costs for on-site work are not covered.
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