Senior Quality Assurance Auditor - Pharmaceutical

Placements24; Gqeberha; Hybride; ZAR 420 000 - 600 000; Plein temps

Avantages offerts par ce poste

Health benefits

Retirement plan

Paid leave

Résumé du poste

Placements24 seeks a Senior Quality Assurance Auditor to join a distinguished pharmaceutical manufacturer in Port Elizabeth, Eastern Cape. The role supports hybrid work, combining remote flexibility with on-site responsibilities.

The incumbent will conduct internal and external audits of facilities, systems, and processes to ensure GMP compliance and regulatory alignment, driving CAPA and continuous quality improvement.

Qualifications

• Bachelor's degree in a relevant scientific field.
• Minimum 4 years in Quality Assurance or Quality Control in pharma with auditing focus.
• Strong knowledge of cGMP regulations (FDA, EMA, SAHPRA) and ICH guidelines.
• Proven experience conducting internal and external audits.
• Excellent analytical, problem-solving and report-writing skills.

Responsabilités

• Plan, conduct, and document internal and external audits of manufacturing sites, contract manufacturers, and suppliers.
• Assess compliance with cGMP, ICH guidelines, and other regulatory requirements.
• Evaluate effectiveness of quality management systems including document control, change control, CAPA, and deviation management.
• Prepare comprehensive audit reports detailing findings and recommendations for corrective actions.
• Follow up on audit findings to ensure timely CAPA implementation.
• Participate in regulatory inspections and support audit teams.
• Develop and refine audit plans and checklists based on risk assessments and regulatory changes.
• Provide training on quality assurance and GMP compliance.

Connaissances

Auditing

GMP knowledge

cGMP

Quality Systems

Regulatory compliance

Formation

Bachelor's degree in Pharmacy, Chemistry, Microbiology

Outils

Microsoft Office

Description du poste

About the Role

Our client, a distinguished pharmaceutical manufacturer, is seeking a meticulous and experienced Senior Quality Assurance Auditor to join their team in Port Elizabeth, Eastern Cape, ZA . This role supports a hybrid work model, combining remote flexibility with essential on-site responsibilities. You will be responsible for conducting internal and external audits of manufacturing facilities, quality systems, and processes to ensure compliance with Good Manufacturing Practices (GMP) and relevant regulatory standards. Your expertise will be critical in identifying areas for improvement and ensuring the highest standards of quality and compliance for our client's pharmaceutical products. This is an opportunity to make a significant impact on product safety and efficacy within a supportive and professional setting.

Key Responsibilities

• Plan, conduct, and document internal and external audits of manufacturing sites, contract manufacturers, and suppliers.
• Assess compliance with cGMP, ICH guidelines, and other applicable regulatory requirements.
• Evaluate the effectiveness of quality management systems, including document control, change control, CAPA, and deviation management.
• Prepare comprehensive audit reports detailing findings, observations, and recommendations for corrective actions.
• Follow up on audit findings to ensure timely and effective implementation of corrective and preventive actions (CAPAs).
• Participate in regulatory inspections and provide support to audit teams.
• Develop and refine audit plans and checklists based on risk assessments and regulatory changes.
• Provide training and guidance to internal teams on quality assurance and GMP compliance.
• Stay updated on evolving regulatory requirements and industry best practices in quality assurance.
• Contribute to the continuous improvement of the company's quality systems.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related scientific field.
• Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry, with a significant portion dedicated to auditing.
• In-depth knowledge of cGMP regulations (e.g., FDA, EMA, SAHPRA) and ICH guidelines.
• Proven experience in conducting internal and external audits.
• Strong understanding of pharmaceutical manufacturing processes and quality systems.
• Excellent analytical, problem-solving, and report-writing skills.
• Proficiency in Microsoft Office Suite.
• Ability to work effectively both independently and as part of a team in a hybrid capacity, based in Port Elizabeth, Eastern Cape, ZA .

Benefits

• Annual salary of R .
• Comprehensive health and retirement benefits.
• Paid annual leave and sick leave.
• Opportunities for professional development and certification.
• Hybrid work model offering flexibility.
• Stable and supportive work environment.