Quality Consultant - Health Authority Audit Remediation & Batch Record Review
Quality Consultant - Health Authority Audit Remediation & Batch Record Review
Direct message the job poster from Mantell Associates
Senior Associate at Mantell Associates - Quality Consultancy
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.
Quality Consultant - Responsibilities:
* Lead and support remediation activities following findings from recent health authority audits (e.g., EMA, FDA, local authorities)
* Perform detailed batch record reviews for manufacturing and packaging processes to ensure GMP compliance
* Identify gaps, deviations, and inconsistencies within documentation and drive corrective and preventive actions (CAPAs)
* Collaborate with QA, QC, production, and regulatory teams to implement robust quality improvements
* 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
Quality Consultant - Requirements:
* Degree in Life Sciences, Pharmacy, or a related field
* Minimum of 8 years’ experience in a GMP-regulated biopharmaceutical or pharmaceutical environment
* Strong expertise in audit remediation, batch documentation review, and quality system compliance
* Experience working in response to EMA, FDA, or other regulatory inspections
* Excellent knowledge of EU GMP and international regulatory standards
* Fluent in English; German language skills are a strong advantage
* Able to work on-site in Munich (hybrid options may be considered for the right candidate)
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance, Legal, and Accounting/Auditing
* Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Engineering Services
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