GMP Compliance Expert
Updated: 04 Dec 2024
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 KaiseraugstWorkload: 100%Home Office: max. 20%Contract Duration: 12 months, with possible extensionsStart 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 ogle 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.