GMP Auditor

Apotech is a Life Science Management Consultancy, delivering outsourced services in Quality and Regulatory Affairs. After three successful years, we are in a growing phase with big ambitions! Fundamental to the business is to continue to create an organisation where employees are excited to come to work, are proud of what we do & who we are and push the boundaries of social responsibilities. We are now seeking a GMP Auditor to join our amazing team. 

Job Title: GMP Auditor

Location: Flexible/Remote or willing to travel onsite within the EU 

Position Overview: We are looking for a skilled and experienced freelance GMP (Good Manufacturing Practice) Auditor to join our team. The ideal candidate will have a strong background in pharmaceutical, biotechnology, or medical device manufacturing, with extensive knowledge of GMP regulations and quality systems. As a freelance auditor, you will be responsible for conducting independent audits of manufacturing facilities, suppliers, and contract manufacturing organisations (CMOs) to ensure compliance with GMP standards and regulatory requirements.

Responsibilities:

• Perform comprehensive audits of manufacturing facilities, including production areas, quality control laboratories, and support functions, to assess compliance with GMP regulations and industry standards.
• Review documentation, records, and procedures related to manufacturing processes, equipment qualification, cleaning validation, and product testing to verify adherence to GMP requirements.
• Evaluate the effectiveness of quality management systems (QMS), including document control, change control, deviation management, and CAPA (Corrective and Preventive Action) processes.
• Conduct supplier audits and assessments of contract manufacturing organizations (CMOs) to evaluate their capabilities, quality systems, and compliance with GMP requirements.
• Identify non-compliance issues, deviations, and areas for improvement during audits, and collaborate with stakeholders to develop corrective action plans and remediation strategies.
• Prepare detailed audit reports documenting findings, observations, and recommendations for corrective actions, and ensure timely follow-up to verify implementation.
• Stay informed about changes in GMP regulations, industry guidelines, and best practices, and guide stakeholders on compliance requirements.
• Communicate effectively with manufacturing personnel, quality assurance professionals, regulatory affairs specialists, and other stakeholders to facilitate audit activities and promote compliance awareness.

Requirements:

• Bachelor’s degree in pharmacy, chemistry, biology, engineering, or a related field. Advanced degree (e.g., master’s or Ph.D.) preferred.
• Extensive experience in pharmaceutical, biotechnology, or medical device manufacturing with a minimum of 5 years working in quality assurance, quality control, or regulatory affairs roles.
• In-depth knowledge of GMP regulations (e.g., FDA 21 CFR Part 210/211, EU GMP Annex 1) and international guidelines governing pharmaceutical manufacturing and quality systems.
• Proven experience conducting GMP audits, either as an internal auditor, third-party auditor, or independent consultant.
• Strong understanding of manufacturing processes, validation principles, risk assessment methodologies, and statistical techniques.