Audit Clerk

Mantell Associates is partnered with a leading biopharmaceutical manufacturer based in Munich, who is seeking an experienced Quality Consultant to support ongoing health authority audit remediation efforts and conduct comprehensive batch record reviews . This role is crucial in ensuring compliance with regulatory expectations and in strengthening the site’s quality oversight following recent inspections. Lead and support remediation activities following findings from recent health authority audits (e.g., Perform detailed batch record reviews for manufacturing and packaging processes to ensure GMP compliance Contribute to quality system updates and documentation improvements in line with global regulatory requirements Prepare audit-ready documentation and support mock audits or re-inspections, if needed Strong expertise in audit remediation, batch documentation review, and quality system compliance Excellent knowledge of EU GMP and international regulatory standards Fluent in English; German language skills are a strong advantage