GLP 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 GLP Auditor to join our amazing team. 

Job Title: GLP Auditor – Freelance  

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

Position Overview: We are seeking a qualified and experienced freelance GLP Auditor to join our team. The ideal candidate will possess a strong background in laboratory operations, regulatory compliance, and GLP standards. As a freelance auditor, you will be responsible for conducting independent assessments of laboratories to ensure compliance with GLP guidelines, applicable regulations, and industry best practices.

Responsibilities:

• Conduct comprehensive GLP audits of laboratory facilities, including analytical laboratories, preclinical testing facilities, and research institutions, to assess compliance with GLP regulations and guidelines.
• Review study protocols, standard operating procedures (SOPs), analytical methods, and other relevant documentation to ensure adherence to GLP standards and regulatory requirements.
• Evaluate laboratory equipment, facilities, and personnel training to ensure the integrity of study data, accuracy of test results, and overall compliance with GLP principles.
• Assess the conduct of preclinical studies, including animal welfare, study design, data collection, and documentation, to ensure adherence to GLP requirements.
• Verify the accuracy and completeness of study documentation, including raw data, study reports, and quality assurance records, to assess the overall quality and reliability of study results.
• Identify deviations, non-compliance issues, and areas for improvement during audits, and collaborate with laboratory personnel to develop corrective and preventive action plans.
• 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 GLP regulations, industry guidelines, and best practices, and guide laboratories on compliance requirements.

Requirements:

• Bachelor’s degree in life sciences, chemistry, biology, or a related field. Advanced degree (e.g., master’s or Ph.D.) preferred.
• Extensive experience in laboratory operations, quality assurance, or regulatory affairs, with a minimum of 5 years working in GLP-regulated environments.
• In-depth knowledge of GLP regulations (e.g., 21 CFR Part 58, OECD Principles of GLP) and other relevant guidelines governing laboratory practices.
• Proven experience conducting GLP audits, either as an internal auditor, sponsor representative, or independent consultant.
• Certification as a GLP Auditor (e.g., RQAP-GLP) or equivalent credential preferred.
• Willingness to travel domestically and internationally as needed to conduct laboratory audits (once travel restrictions are lifted).