Compliance Expert (m/w/d)

For a renowned client, we are looking for

at the earliest possible date:

Compliance Expert (m/w/d) GMP | Pharmaceutical Production

Your tasks:

• Ensuring GMP-compliant processes in the production areas you supervise – from documentation to operational implementation

• Coordination and maintenance of the SOP landscape as well as support with GQD reviews and their implementation as a technical expert

• Qualification planning and coordination for materials, especially Single-Use-Systeme, as well as ensuring that only specification-compliant starting materials are used

• Development and maintenance of a practical training concept for employees in the MLP manufacturing area

• Processing of process deviations and changes within the framework of established quality systems, e.g., via change or improvement management (CAPAs)

• Supporting the operational team in the creation of documents and concepts – from logbooks to manufacturing instructions to templates

• Review of manufacturing documents as well as preparation and accompaniment of internal and external inspections

Your profile:

• You have more than 5 years of professional experience in a GMP-regulated production environment, whether as a Quality Assurance Specialist (m/w/d), GMP Compliance Manager (m/w/d), Regulatory Affairs Specialist (m/w/d) or in a comparable function in the pharmaceutical or biotechnological environment

• Strong understanding of efficient, at the same time GMP-compliant processes and their documentation

• Independent, structured and solution-oriented way of working – you drive topics forward on your own responsibility

• Excellent communication skills for targeted exchange between production, quality, and technical departments

• Experience with audits – whether authority audits, global inspections or comparable formats

• Fluent English skills in spoken and written form

• Knowledge of document management and training systems, ideally Geode and iLearn

Your advantages:

• Assignment at an internationally established pharmaceutical company in the Industriepark Höchst, Frankfurt am Main

• Remuneration according to the equal pay principle with attractive grading (L2-2)

• Working time sovereignty - independent design of your working hours within the framework of project specifications

• Long-term assignment with a realistic perspective of being taken over by the client company

• Personal support by BS during the entire assignment