Job Description

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.

Tasks & Responsibilities:

Monitoring & Trending: Independently create, evaluate, and interpret 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: Assess key performance indicators (KPIs) of operational compliance and conduct logbook checks, as well as reviews of monitoring data for plausibility and data integrity. Compliance Assurance: Ensure compliance with official and regulatory requirements in day-to-day operations and implement Pharma Quality System (PQS) requirements (GSP). Deviation Management: Initiate and process documents in the Quality Veeva Vaults systems (Deviation / Change / CAPA), especially in the case of anomalies in media monitoring. GMP Support: Serve as the primary contact person for employees with GMP-related questions (GMP Coach) and support 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: First point of contact for employees regarding GMP-related questions (GMP coach), conducting training sessions, and supporting the Circles to ensure GMP-compliant operations.

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 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 sustainable understanding of GMP and quality awareness within the team is essential. The candidate must be able
to work independently and
be fluent in both written and spoken German and English.

Reference No

.: 924633

Role

: Specialist for Operational Compliance (m/f/d)

Industry

: Pharmaceuticals

Location

: Basel & Kaiseraugst

Workload

: 80%-100%

Start Date

: February 1, 2026 (Latest start date: April 1, 2026)

Duration

: 12 months

Application Deadline

: December 10, 2025

Job Type: 80-100%

Work Location: On the road