Fachexperte Betriebliche Compliance (w/m/d)

Operational Compliance Specialist (m/f/d) - Pharmaceutical Media Systems/ Process Water/ WBI/ WFI/ Gas Supply Systems/ GMP/ RHI/ FDA/ EMA/ Qualification/ Validation/ CAPAs/ Quality Data/ Alarms/ Action Limits/ OOt/ OOS/ Deutech/ English Project: For our pharmaceutical customer based in Basel, we are looking for an Operational Compliance Specialist (m/f/d)

Background: 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 innovative ways. We collaborate with all stakeholders along the entire value chain, from early research to patient care. With us, you can look forward to a modern organizational model in which you can contribute your talents to meaningful work with autonomy. We guarantee creative freedom and decision-making authority within our organization. You won't find traditional supervisors here.

The Energies and Utilities division is responsible for supplying energy and utilities to the sites in Basel and Kaiseraugst. We 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.

The ideal candidate is a positive, ethical, and self-reflective individual with strong communication skills. They possess a structured work style and pronounced logical and analytical thinking abilities, particularly when dealing with complex datasets. The candidate is comfortable in a regulated environment and confidently represents the Energies and Utilities sector in audits.

Aufgaben & Verantwortlichkeiten:
• Monitoring & Trending: Eigenverantwortliche Erstellung, Bewertung und Interpretation von Trending-Berichten für kritische Prozess Medien (PW, Gase). Du erkennst frühzeitig Trends (Out of Trend - OOT) und leitest präventive Massnahmen ein, bevor Grenzwerte verletzt werden.
• Datenanalyse: Beurteilung von Kennzahlen der betrieblichen Compliance und Durchführung von Logbuchkontrollen sowie Reviews der Monitoring-Daten auf Plausibilität und Datenintegrität.
• Sicherstellung Compliance: Gewährleistung der behördlichen und regulatorischen Vorgaben im operativen Betrieb sowie Umsetzung der Pharma Quality System-Vorgaben (PQS, GSP).
• Abweichungsmanagement: Initiieren und Bearbeiten von Dokumenten in den Quality Veeva Vaults Systemen (Deviation / Change / CAPA), insbesondere bei Auffälligkeiten im Medien-Monitoring.
• GMP-Support: Erster Ansprechpartner für Mitarbeitende bei GMP-relevanten Fragestellungen (GMP-Coach) und Unterstützung der Circles zur Sicherstellung eines GMP-konformen Betriebs.
• Inspektionsbereitschaft: Gewährleistung der Inspektionsbereitschaft (Front- und Backoffice) und Koordination der Subject Matter Experts (SMEs) bei Behördeninspektionen.
• Dokumentation: Bearbeitung übergeordneter SOPs und Unterstützung bei der Umsetzung von PQS-Vorgaben in den Dokumenten des Prozess Management Systems.
• GMP-Support & Training: Erster Ansprechpartner für Mitarbeitende bei GMP-relevanten Fragestellungen (GMP-Coach), Durchführung von Schulungen und Unterstützung der Circles zur Sicherstellung eines GMP-konformen Betriebs.

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p>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 limits, and experience in evaluating OOT/OOS results • Ability to recognize cross-system correlations from monitoring data and to prepare reports graphically and in terms of content with precision • Very good computer skills (MS Office, Google Suite). Advanced knowledge of Excel and gSheet is essential for efficient data processing and trend visualization . Experience in conducting GMP training and instruction for operational staff is required. The ability to clearly communicate complex compliance topics to ensure a lasting understanding of GMP and quality awareness within the team is essential . The can j4id9971013a j4it1249a j4iy25a