Pharma QA: GMP Compliance & Audit Lead

Placements24; Stellenbosch; Sur place; ZAR 700 000 - 900 000; Plein temps

Avantages offerts par ce poste

Medical aid

Provident fund

Paid time off

Professional growth opportunities

Résumé du poste

Placements24 is seeking a detail-oriented Pharmaceutical Quality Assurance Specialist to join our Stellenbosch team. The role focuses on ensuring compliance with GMP, ICH guidelines, and internal quality standards across pharmaceutical operations.

You will oversee audits, document control, CAPA initiatives, and quality improvement projects, supporting patient safety and regulatory compliance in a highly regulated industry.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, or Biology.
• Minimum of 4 years in Quality Assurance within the pharmaceutical industry.
• Thorough understanding of GMP, ICH guidelines, and regulatory standards.
• Proven experience in conducting internal audits and managing external inspections.
• Strong quality management skills: document control, change control, deviation handling, and CAPA.
• Analytical mindset with meticulous attention to detail and problem-solving.
• Excellent communication and interpersonal skills with auditors and staff.
• Proficiency with quality management software and standard office tools.

Responsabilités

• Develop, implement, and maintain the Quality Management System (QMS) in line with regulatory requirements.
• Conduct internal audits of departments to ensure GMP and SOP compliance.
• Co-ordinate external audits by regulatory authorities and customers.
• Review and approve key quality documents, including SOPs and change controls.
• Investigate deviations and CAPAs, and address customer complaints.
• Participate in supplier qualification and ongoing supplier management.
• Monitor quality metrics and prepare management reports.
• Provide training on QA principles and GMP compliance.
• Stay updated with evolving regulatory requirements and best practices.

Connaissances

Quality assurance

Audits

GMP compliance

Regulatory standards

Formation

Bachelor’s degree in Pharmacy, Chemistry, Biology

Outils

QMS software

Description du poste

Placements24 is seeking a detail-oriented Pharmaceutical Quality Assurance Specialist to join our Stellenbosch team. The role focuses on ensuring compliance with GMP, ICH guidelines, and internal quality standards across pharmaceutical operations.

You will oversee audits, document control, CAPA initiatives, and quality improvement projects, supporting patient safety and regulatory compliance in a highly regulated industry.