GMP Compliance Expert.

About the Opportunity:

On behalf of our client, we are looking for a GMP Compliance Expert to support compliance and quality assurance processes related to utility systems, including process water, air, and gases in a GMP-regulated environment. This role involves ensuring adherence to regulatory requirements and maintaining operational excellence at two critical sites. The ideal candidate thrives in a dynamic, collaborative environment and brings a strong background in compliance and quality assurance within regulated industries.

Position Title: GMP Compliance Expert (m/f/d)

Location: Basel and Kaiseraugst

Workload: 100%

Home Office: max. 20%

Contract Duration: 12 months, with possible extensions

Start Date: ASAP, no later than 01.04.2025

Main Responsibilities:

• Ensure compliance with regulatory and operational standards for utility systems (process water, air, and gases) in a GMP environment.
• Manage deviation, change, risk, and improvement processes.
• Act as an advisor on technical GMP matters, supporting documentation and process updates.
• Develop, review, and maintain process management documentation.
• Drive continuous improvement by evaluating and implementing updates to cGMP standards.
• Create compliance reports (e.g., trend analysis) and monitor KPIs, initiating corrective actions as needed.
• Conduct logbook reviews and collaborate with the technical compliance team.

Profile and Requirements:

• Completed vocational training or a Bachelor's/Master's degree, ideally in pharmaceutical manufacturing or a related field.
• Minimum 3 years of experience in compliance or quality assurance for technical or pharmaceutical systems within GMP-regulated environments.
• Familiarity with implementing technical GMP requirements from regulatory bodies (e.g., FDA, EMA).
• Proficiency in IT tools, including Google Suite, with an ability to quickly adapt to new programs.
• Fluency in German (spoken and written) is required; English is an asset.
• Strong communication and interpersonal skills, with the ability to build effective relationships.
• Independent and structured approach to managing complex tasks and priorities.

We are looking for a motivated professional with a proactive mindset to join our client's dynamic team. If you meet the qualifications and are ready to contribute your expertise, we encourage you to apply.