EU-GMP Auditor

Company Description

Merit Method specializes in compliance and quality support for the pharmaceutical and cannabis industries. Acting as either an internal audit team or an independent third party, Merit Method conducts audits aligned with EU-GMP and GACP standards. Their services include facility validation, audit remediation, and ensuring systems meet global regulatory requirements. Merit Method is committed to providing tailored solutions to maintain and enhance industry compliance.

Role Description

This is a full-time remote position for an EU-GMP Auditor. The role involves planning, conducting, and reporting on audits to ensure compliance with EU-GMP and GACP standards. The EU-GMP Auditor will review manufacturing processes, assess quality systems, identify areas of improvement, and provide recommendations for corrective actions. The role will also require collaboration with clients to offer guidance on regulatory compliance and audit preparation and follow-up.

Qualifications

• Comprehensive knowledge of EU-GMP, GACP standards, and international regulatory requirements.
• Proven experience with auditing, quality assurance, and regulatory compliance processes.
• Strong report writing, analytical skills, and attention to detail.
• Effective communication, collaboration, and problem-solving abilities.
• Ability to work independently, manage multiple audits, and meet deadlines effectively.
• Bachelor’s degree in a related field such as Life Sciences, Pharmacy, or Quality Assurance.
• Previous experience in the pharmaceutical or cannabis industry is highly beneficial.