Internal Auditor – Regulatory Af...

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Bourj Alarab, Alexandria

Internal Auditor – Regulatory Affairs & Quality Assurance (RA/QA)

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Bourj Alarab, AlexandriaPosted 3 days ago

25Applicants for1 open position

Experience Needed:

Career Level:

Education Level:

Salary:

Job Categories:

1. Audit:

Plan and execute internal audits of Regulatory Affairs and Quality Assurance processes to ensure implementation is performed as planned.

Evaluate the effectiveness of implementation of Quality Management Systems (QMS), including SOPs, CAPA, change control, and documentation practices.

2. Reporting & Follow-Up:

Prepare detailed audit reports with findings, recommendations, and action plans for management.

Track corrective actions to ensure timely closure and compliance.

Present audit results to Top Management.

Work with cross-functional teams to ensure audit findings are resolved.

Required:

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Business, or related field.

3+ years of experience in internal auditing, compliance, or QA/RA roles (pharma, medical devices).

Strong knowledge of EU MDR, FDA, ISO 9001/13485/14971, GMP regulations.

Certifications (preferred): CIA (Certified Internal Auditor), CQA (Certified Quality Auditor), or RAC (Regulatory Affairs Certification).

Key Competencies:

Analytical & Detail-Oriented – Strong ability to assess compliance gaps and recommend solutions.

Communication Skills – Ability to explain complex regulations to non-compliance teams.

Problem-Solving – Proactive in identifying risks and driving process improvements.

Ethical & Independent – Maintains objectivity and confidentiality in audits.