GMP Auditor
About the Role
As an Auditor, you will play a key role in ensuring high standards across internal processes, external partners, and regulatory compliance frameworks. You’ll be involved in auditing operations, suppliers, and customers, supporting continuous improvement initiatives and helping the organisation maintain robust Quality Management System (QMS) standards
Key Responsibilities
Internal Audits
* Conduct internal audits to assess QMS effectiveness and regulatory compliance.
* Evaluate internal controls and operational processes, identifying risks and driving improvements.
* Review processes against industry standards and data protection requirements.
* Produce clear, detailed audit reports with practical recommendations.
* Work with cross‑functional teams to support corrective and preventive actions (CAPA).
* Follow up on previous audit actions to ensure they are implemented effectively.
External Audits
* Lead external audits to ensure compliance with relevant industry and regulatory standards.
* Audit suppliers and customers to verify contractual, operational, and compliance obligations.
* Collaborate with external agencies and provide information to support compliance reporting.
* Communicate findings and improvement strategies to stakeholders.
Supplier & Customer Auditing
* Assess suppliers for quality, documentation control, service delivery, and regulatory adherence.
* Review customer technical agreements and ensure alignment with quality standards.
* Partner with procurement and customer teams to identify risks and recommend improvements.
Skills, Experience & Qualifications
* Degree in Pharmaceutical Science or a related discipline.
* Lead Auditor experience or formal auditor training (e.g., ISO 9001, ISO 13485, GDP/GMP).
* Strong understanding of quality systems and regulated manufacturing environments.
* Experience with regulatory inspections (MHRA, FDA, EMA or similar).
* Knowledge of supplier/vendor management within regulated industries.
* Excellent understanding of risk management and internal controls