Specialist in Operational Compliance

For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Specialist in Operational Compliance. General Information: Start Date: 01.02.2026 Latest Possible Start Date: 01.04.2026 Duration: 1 year with the possibility of extension Home Office: possible, 1-2 days Team: 10 team members Department: Basel Site Services Chapter I (EFHCC) Working Hours: Standard About the position The organization “Site Network Basel / Kaiseraugst”, part of the global Group Function “Corporate Strategy, Sustainability & Sites”, provides the infrastructure and services for the entire site and continuously develops them in an innovative way. They collaborate with all stakeholders along the entire value chain, from early research to patient care. With them, you can look forward to a modern organizational model where you can contribute your talents to meaningful work with autonomy. They guarantee creative freedom and decision‑making authority within our organization. You won't find traditional superiors here. The Energies and Utilities division is responsible for supplying energy and utilities to the sites in Basel and Kaiseraugst. They operate smart, sustainable, reliable, and regulatory‑compliant energy, utilities, and site systems. Ensuring regulatory and GMP compliance for the relevant systems, energy, and utilities will be your primary responsibility. Who you are: A positive, ethical, and self‑reflective individual with excellent communication skills. Possess a structured work style and strong logical and analytical thinking skills, particularly when working with complex datasets. Comfortable working in a regulated environment and confidently represents the Energies and Utilities sector in audits. Task & 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 preventive measures before limits are exceeded. Data Analysis: Assessment of key performance indicators for operational compliance and execution of logbook checks as well as reviews of monitoring data for plausibility and data integrity. Compliance Assurance: Ensuring compliance with official and regulatory requirements in operational procedures as well as implementation of Pharma Quality System requirements (PQS, GSP). Deviation Management: Initiating and processing documents in the Quality Veeva Vaults systems (Deviation / Change / CAPA), especially in the case of anomalies in media monitoring. GMP Support: First point of contact for employees with GMP‑related questions (GMP Coach) and support for 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. Must-haves: Completed technical degree or vocational training with relevant further education in the aforementioned field. Minimum 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 graphically and substantively precise. Very good IT skills (MS Office, Google Suite). In particular, advanced knowledge of Excel and Google Sheets is mandatory for efficient data processing and trend visualization. Experience in conducting GMP training and instruction for operational staff. Ability to communicate complex compliance topics clearly to ensure a sustainable understanding of GMP and quality awareness within the team. Fluent German and English, both written and spoken Sounds interesting? Apply Now We look forward to receiving your application. Application Submission Deadline: 10.12.2025 Seniority level Associate Employment type Contract Job function Other Industries Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr