Pharma QA Lead – GMP, Regulatory & Audits

Placements24; Gqeberha; On-site; ZAR 1,000,000 - 1,500,000; Full time

Benefits offered by this job

Medical aid

Retirement fund contributions

Relocation assistance

Career progression opportunities

Job summary

Placements24 is seeking a Pharmaceutical Quality Assurance Manager in Port Elizabeth to lead a QA team, ensuring GMP compliance and high-quality products. You will drive continuous improvement, manage audits, and serve as the primary liaison for regulatory inspections to ensure patient safety and regulatory adherence.

The role requires 8+ years in QA within the pharmaceutical industry, strong leadership, and a proven track record in change control, CAPA, and risk assessment.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, or related life science; advanced degree preferred.
• Minimum of 8 years of progressive QA experience in the pharmaceutical industry.
• Strong understanding of GMP, ICH guidelines, and regulatory requirements.
• Proven experience in managing QA operations and leading QA teams.
• Excellent leadership, communication, problem-solving, and decision-making skills.
• Experience with regulatory inspections and audits in Port Elizabeth or similar environments.

Responsibilities

• Develop, implement, and maintain QA programs and systems aligned with GMP and regulatory requirements.
• Lead and manage the QA team, providing guidance, training, and performance management.
• Oversee all quality activities including batch record review, deviations, CAPA, change control, audits.
• Ensure compliance with SAHPRA and other international guidelines.
• Conduct risk assessments and implement mitigation strategies to ensure product quality and patient safety.
• Act as primary contact for regulatory inspections and customer audits.

Skills

GMP knowledge

ICH guidelines

QA leadership

Audit management

Regulatory compliance

Problem solving

Communication skills

Education

Bachelor's degree in Pharmacy, Chemistry or related life science

Advanced degree preferred

Job description

Placements24 is seeking a Pharmaceutical Quality Assurance Manager in Port Elizabeth to lead a QA team, ensuring GMP compliance and high-quality products. You will drive continuous improvement, manage audits, and serve as the primary liaison for regulatory inspections to ensure patient safety and regulatory adherence.

The role requires 8+ years in QA within the pharmaceutical industry, strong leadership, and a proven track record in change control, CAPA, and risk assessment.