Responsibilities:
* Monitoring & Trending: Independent creation, evaluation, and interpretation of trending reports for critical process media (PW, gases). You identify trends early (Out of Trend - OOT) and initiate preventative measures before limits are exceeded.
* Data Analysis: Assessing key performance indicators (KPIs) for operational compliance and conducting logbook checks, as well as reviewing monitoring data for plausibility and data integrity.
* Compliance Assurance: Ensuring compliance with official and regulatory requirements in day-to-day operations and implementing Pharma Quality System (PQS) requirements (GSP).
* Deviation Management: Initiating and processing documents in the Quality Veeva Vaults systems (Deviation / Change / CAPA), particularly in the case of anomalies in media monitoring.
* GMP Support: Serving as the primary contact for employees with GMP-related questions (GMP Coach) and supporting the Circles to ensure GMP-compliant operations.
* Inspection Readiness: Ensuring inspection readiness (front and back office) and coordinating Subject Matter Experts (SMEs) during regulatory inspections.
* Documentation: Processing overarching SOPs and supporting the implementation of PQS requirements in the Process Management System documents.
* GMP Support & Training: Primary contact for employees regarding GMP-related questions (GMP Coach), conducting training sessions, and supporting the Circles to ensure GMP-compliant operations.
Requirements:
* Completed technical degree or vocational training with relevant further education in the aforementioned field
* Fluent in German and English
* Minimum of 3 years of experience in creating and interpreting trend analyses for pharmaceutical media systems (water, gases)
* Initial professional experience in a company with process water (WBI/WFI) and/or gas supply systems in a GMP environment, as well as knowledge of qualification and validation
* Practical experience in implementing technical GMP requirements of regulatory authorities (RHI, FDA, EMA, etc.) and in processing deviations, changes, and CAPAs
* Confident handling of quality data, understanding of alarm and action thresholds, and experience in evaluating OOT/OOS results
* Ability to identify cross-system correlations from monitoring data and to prepare reports with graphical precision and clarity
* Excellent computer skills (MS Office, Google Suite). Advanced knowledge of Excel and gSheet is essential for efficient data processing and trend visualization.
* Experience conducting GMP training and instruction for operational staff
* Ability to explain complex compliance topics clearly and understandably to enhance GMP understanding
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