GMP Compliance Auditor
7 hours ago
Sheffield
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., • 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., • 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., • 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, • 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.