Internal Compliance Auditor

Job Description

Reporting to: Supplier Quality Assurance Manager

Key Responsibilities

• Plan, organize, and manage internal and supplier audit schedules (as applicable), ensuring they are aligned with both company and regulatory requirements.
• Oversee the execution of internal GMP (21 CFR 212) and external audits (as applicable), ensuring audits are conducted in a thorough and consistent manner.
• Review and approve audit reports, ensuring that findings are clearly documented, supported by evidence, and aligned with internal and regulatory requirements.
• Monitor the follow-up of audit findings, ensuring that corrective and preventive actions are implemented effectively and in a timely manner.
• Ensure proper documentation and archiving of all audit reports, evidence, and follow-up activities.
• Collaborate with relevant departments to address audit findings, improve processes, and foster a culture of continuous improvement.
• Stay updated on changes in regulatory requirements and industry best practices for auditing.
• Develop and provide training sessions for internal teams on audit performance, preparedness, and quality standards.
• Analyze audit results and trends to identify areas for systemic improvement and report these insights to senior management.
• Represent the QA department in cross-functional meetings related to audit findings, strategies, and improvements.
• Engage in travel as required for supplier or site audits, as well as for professional development or industry conferences.
• Other duties as required by management.

Minimum Requirements

• Bachelor's degree in fields such as Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline. A degree in Business Administration or Accounting can also be relevant if combined with industry-specific experience.
• ASQ Certified Quality Auditor (CQA) required or equivalent.
• Multiple years of experience in quality assurance auditing, specifically within the pharmaceutical or related industry.
• Comprehensive knowledge of pharmaceutical industry regulations, including GMPs, ISO standards, FDA guidelines, and other relevant standards.
• Strong analytical, organizational, and communication skills.
• Ability to handle sensitive information with integrity and confidentiality.