Job Description
* The GMP Compliance Auditor is responsible for planning, conducting, and reporting on Good Manufacturing Practice (GMP) audits for pharmaceutical, biotechnology, medical device, and life sciences organizations.
* This role ensures that internal operations, suppliers, manufacturing sites, and quality systems comply with UK, EU, and international GMP regulations (MHRA, EU GMP, FDA 21 CFR Part 210/211, ICH guidelines, etc.).
* This position is fully remote within the UK, with occasional travel for on-site supplier audits or regulatory inspections.
Key Responsibilities
GMP Audit Planning & Execution
* Plan, prepare, and perform GMP audits for internal operations, contract manufacturers, suppliers, and third-party service providers.
* Conduct audits in accordance with MHRA, EMA/EU GMP, FDA, WHO, and ICH Q-series guidelines.
* Assess compliance of manufacturing, laboratory operations, quality systems, documentation, and operational processes.
* Identify non-conformances and areas for improvement, conducting root-cause analysis where required.
Documentation & Reporting
* Prepare detailed audit reports summarizing findings, compliance gaps, and corrective/preventive action (CAPA) recommendations.
* Track and monitor CAPA progress to ensure timely closure and continual compliance.
* Maintain audit records in accordance with QMS and regulatory requirements.
Regulatory Compliance Monitoring
* Keep updated on changes to GMP regulations, MHRA expectations, EU Annex guidelines, FDA requirements, and ICH standards.
* Support internal teams and clients during MHRA, FDA, EMA, and other regulatory inspections.
* Assist with maintaining compliance documentation, SOPs, and QMS updates.
Quality System Evaluation
* Assess key elements of GMP quality systems, including:
* Document control
* Batch record review
* Change control
* Deviation & CAPA management
* Training compliance
* Facility & equipment qualification
* Validation (process, cleaning, CSV)
* Supplier qualification
* Provide recommendations to strengthen overall quality compliance.
Cross-Functional Collaboration
* Partner with Quality Assurance (QA), QC, Manufacturing, Supply Chain, and Validation teams.
* Communicate audit outcomes to senior quality leaders and cross-functional stakeholders.
* Support training and guidance on GMP compliance best practices.
Required Qualifications
* Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related field.
* 3–5+ years of experience in GMP auditing, QA, regulatory compliance, or pharmaceutical manufacturing.
* Strong knowledge of: UK MHRA GMP, EU GMP (including Annexes), FDA 21 CFR Parts 210/211 & ICH guidelines (Q7, Q8, Q9, Q10, etc.).
* Experience conducting internal, supplier, or third-party GMP audits.
* Excellent understanding of pharmaceutical/life sciences quality systems.
* Strong written skills for regulatory documentation and audit reporting.