Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, or related field; Business Administration or Accounting acceptable with relevant experience.
ASQ Certified Quality Auditor (CQA) or equivalent certification required.
Several years of experience in quality assurance auditing within the pharmaceutical industry.
In-depth knowledge of pharmaceutical regulations, including GMPs, ISO standards, and FDA guidelines.
Strong analytical, organizational, and communication skills.
Ability to manage sensitive information with confidentiality.
Responsibilities
Plan and manage internal and supplier audit schedules to meet company and regulatory standards.
Oversee execution of internal GMP and external audits, ensuring thoroughness and consistency.
Review and approve audit reports, ensuring findings are well-documented and evidence-based.
Monitor follow-up on audit findings, ensuring timely implementation of corrective actions.
Ensure proper documentation and archiving of all audit-related materials.
Collaborate with departments to address audit findings and promote continuous improvement.
Stay updated on regulatory changes and industry best practices for auditing.
Develop and conduct training sessions on audit performance and quality standards.
Benefits
Opportunity for professional development through industry conferences and training.
Engagement in cross-functional collaboration to enhance audit processes.
Exposure to a dynamic regulatory environment with continuous learning opportunities.
Potential for travel to supplier sites and audits, enhancing industry experience.
Full Job Description
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.
