Project Business Analyst: Business Analyst / Projektleiter / GxP / CSV / Synthetic Molecules / GMP / Produktionsprozesse / English / Deutsch

Project

For our client, a large pharmaceutical company based in Basel, we are looking for a Project Business Analyst.

Background

The Paperless Workstream within the Synthetic Molecules Facility (SMF) in Basel aims to identify manual, paper-based processes and replace them with digital solutions. The main project is the introduction of the eLogbook. We are looking for an expert for the definition and execution phase of this digitalization project.

The perfect candidate has more than 10 years of experience as a Business Analyst and Project Manager for digitalization projects in the Pharma GMP environment. Demonstrable experience in creating validation-compliant URS and specifications (GxP / CSV) and a solid understanding of development and production processes in the Pharma (Synthetic Molecules) field are also mandatory.

Tasks & Responsibilities

• Erhebung & Analyse: Systematic recording of business requirements for the eLogbook directly from stakeholders in production and quality (SMF).
• Priorisierung: Evaluation and structuring of requirements in close coordination with process owners.
• Dokumentation: Creation of User Requirements Specifications (URS) as well as functional specifications.
• Data Strategy: Definition of requirements for data architecture and determination of data ownership for the eLogbook as a data product.
• Organisation des Solutioning: Setting up a team that can provide solutions for the requirements. Ensuring that solution concepts meet the requirements and are feasible.
• Planung der Ausführung: Creating a roadmap for execution and developing a detailed schedule. Cost estimation of the execution and cross-checking with available budgets. Setting up the implementation team, ensuring that resources are available.
• Überwachung der Ausführung: Ensuring that the requirements are implemented with the required quality and within the given timelines.
• Schnittstelle: Acts as an interface and coordinator between the user/client and the executing teams.

Must Haves

• Ideally process engineering or similar education/studies.
• At least 10 years of experience in Business Analysis in a Pharma GMP environment.
• At least 10 years of experience as a Project Manager for digitalization projects in a Pharma GMP environment.
• Demonstrable experience in creating validation-compliant URS and specifications (GxP / CSV).
• Understanding of development and production processes in Pharma (Synthetic Molecules).
• Very good IT/ tool knowledge.
• Strong communication and moderation skills in German to precisely extract requirements from the shop floor.
• English (business fluent).

Details

• Reference Nr.:
• Rolle: SMF Project Business Analyst- PaperlessLogbook
• Industrie: Pharma
• Location: Basel
• Pensum: 50-100% (depending on candidate's experience)
• Start: Asap /
• Duration: 6++ Months
• Deadline: 18/03/2026

If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs(at)itcag(dot)com.

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About us

ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.