Fachexperte Betriebliche Compliance m/f/d, Basel-Stadt This 1-year contract position (with possible extension) focuses on monitoring and ensuring the GMP-compliant operation of critical pharmaceutical media systems such as purified water and gases. The role is responsible for independently creating and interpreting trend reports, identifying early deviations, and initiating preventive actions. Key tasks include data analysis, KPI evaluation, logbook reviews, and ensuring data integrity. The position supports regulatory compliance by managing deviations, changes, and CAPAs within Quality Veeva Vault, preparing for inspections, and coordinating SMEs during audits.
Acting as a GMP Coach, the role provides guidance and training to operational teams, supports implementation of Pharma Quality System (PQS) requirements, and contributes to SOP development and documentation management.
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 prevenative 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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