Quality Assurance Auditor

Placements24; Gqeberha; Hybrid; ZAR 700.000 - 1.100.000; Vollzeit

Benefits dieser Stelle

Health insurance

Home office setup allowance

Travel expense support

Professional development opportunities

Paid time off

Zusammenfassung

Placements24 seeks a diligent Quality Assurance Auditor for a predominantly remote role with travel to supplier sites and internal facilities in the Eastern Cape region. You will conduct internal and supplier audits to ensure GMP compliance, evaluate findings, and drive CAPA actions while supporting regulatory inspections.

The ideal candidate has 5+ years in QA/QC in pharma, strong report writing, and proficiency with GMP and ICH guidelines.

Qualifikationen

• Bachelor’s degree required in a scientific discipline.
• Minimum 5 years' QA/QC experience in pharma.
• Proven GMP audit experience (internal and external).
• GMP knowledge, ICH guidelines and regulatory frameworks.
• Excellent report writing and documentation skills.

Aufgaben

• Plan and execute internal audits of manufacturing processes, quality systems, and documentation.
• Conduct supplier audits to assess compliance with cGMP and contractual requirements.
• Evaluate audit findings, prepare comprehensive audit reports, and recommend CAPA.
• Follow up on CAPA implementation and verify effectiveness.
• Ensure compliance with national and international regulatory standards (e.g., SAHPRA, FDA, EMA).
• Participate in regulatory inspections and support the preparation of responses.
• Develop and maintain audit checklists and procedures.
• Stay current with evolving GMP regulations and industry best practices.
• Provide training to internal staff on quality assurance principles and audit processes.
• Contribute to the continuous improvement of the Quality Management System.

Kenntnisse

GMP audits

Audit planning

Analytical thinking

Report writing

Regulatory communication

Time management

Ausbildung

Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific discipline

Tools

Microsoft Office Suite

Jobbeschreibung

About the Role

Our client, a distinguished pharmaceutical manufacturer, is seeking a highly diligent Quality Assurance Auditor to join their expanding team. This role will be primarily responsible for conducting internal and external audits to ensure compliance with Good Manufacturing Practices (GMP) and other relevant quality standards. As this position is predominantly remote, you will have the flexibility to conduct audits virtually and travel as needed to supplier sites and internal facilities. Your expertise will be crucial in maintaining the highest standards of quality and regulatory compliance for our pharmaceutical products. This is an excellent opportunity for a detail-oriented professional to make a significant impact on product safety and efficacy within a company that values integrity and excellence. The Eastern Cape region offers a unique environment for this critical quality role.

Key Responsibilities

• Plan and execute internal audits of manufacturing processes, quality systems, and documentation.


• Conduct supplier audits to assess compliance with cGMP and contractual requirements.


• Evaluate audit findings, prepare comprehensive audit reports, and recommend corrective and preventative actions (CAPA).


• Follow up on CAPA implementation and verify effectiveness.


• Ensure compliance with national and international regulatory standards (e.g., SAHPRA, FDA, EMA).


• Participate in regulatory inspections and support the preparation of responses.


• Develop and maintain audit checklists and procedures.


• Stay current with evolving GMP regulations and industry best practices.


• Provide training to internal staff on quality assurance principles and audit processes.


• Contribute to the continuous improvement of the Quality Management System.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.


• Minimum of 5 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.


• Demonstrated experience in conducting GMP audits, both internal and external.


• In-depth knowledge of GMP regulations and quality system requirements.


• Familiarity with ICH guidelines and other relevant regulatory frameworks.


• Excellent analytical, critical thinking, and problem-solving skills.


• Strong report writing and documentation skills.


• Ability to work independently, manage time effectively, and travel as required.


• Excellent interpersonal and communication skills.


• Proficiency in Microsoft Office Suite.

Benefits

Our client offers a competitive salary package, a comprehensive health insurance plan, and retirement benefits. We provide a dedicated home office setup allowance and support for necessary travel expenses. Opportunities for professional development include advanced training, certifications, and participation in industry conferences. This remote role offers significant flexibility and autonomy. You will be part of a team committed to upholding the highest quality standards in pharmaceutical manufacturing. We offer generous paid time off and a supportive work environment. Join an organization that is dedicated to ensuring patient safety and the efficacy of its products, contributing to better health outcomes globally.