Corporate Compliance Specialist

Vor 2 Tagen

Basel, Schweiz Actalent Vollzeit

Direct message the job poster from Actalent We are looking for our client for a Corporate Compliance Specialist to join the Energies and Utilities team at the Basel & Kaiseraugst sites. This team ensures the reliable, sustainable, and compliant supply of energy and media across the entire site. In this role, you will play a key part in guaranteeing regulatory and GMP compliance for critical systems, energies, and media. Responsibilities Monitoring & Trending: Independently create, evaluate, and interpret trending reports for critical process media (e.g., purified water, gases). Detect early trends (OOT) and initiate preventive measures before limits are exceeded. Data Analysis: Assess compliance KPIs, perform logbook checks, and review monitoring data for plausibility and data integrity. Compliance Assurance: Ensure adherence to regulatory requirements and implement Pharma Quality System standards (PQS, GSP) in daily operations. Deviation Management: Initiate and process documents in Quality systems (Deviation / Change / CAPA), especially for anomalies in media monitoring. GMP Support: Act as the first point of contact for GMP-related questions, provide coaching, and support teams in maintaining GMP‑compliant operations. Inspection Readiness: Guarantee readiness for inspections (front and back office) and coordinate SMEs during regulatory audits. Documentation: Maintain overarching SOPs and support the implementation of PQS requirements in process management documentation. Training: Conduct GMP training sessions and promote quality awareness within operational teams. Must-Haves Completed technical degree or vocational training with relevant further education. Minimum 3 years of experience in creating and interpreting trend analyses for pharmaceutical media systems (water, gases). Hands‑on experience with process water (WBI/WFI) and/or gas supply systems in a GMP environment, including qualification and validation. Practical knowledge of implementing technical GMP requirements from regulatory authorities (e.g., FDA, EMA) and handling Deviations, Changes, and CAPAs. Strong ability to work with quality data, understand alarm/action limits, and evaluate OOT/OOS results. Skilled in identifying cross‑system correlations from monitoring data and preparing clear, precise reports. Advanced IT skills (MS Office, Google Suite), especially Excel and Google Sheets for data processing and trend visualization. Experience delivering GMP training and explaining complex compliance topics in an understandable way. Independent working style, fluent in German and English (spoken and written). Start Date: Feb 2026 Duration: 12 months If you want to learn more about this opportunity please feel free to reach out directly to mbertrand@actalentservices.com. *While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates. Seniority level Associate Employment type Full‑time Job function Consulting Industries: Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Actalent by 2x Get notified about new Compliance Specialist jobs in Basel, Basel, Switzerland. #J-18808-Ljbffr

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