Pharmaceutical Quality Assurance Manager

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

About the Role

Our client is seeking a highly qualified Pharmaceutical Quality Assurance Manager to oversee and enhance their quality management systems in Port Elizabeth . This leadership role is responsible for ensuring that all pharmaceutical manufacturing processes and products adhere to stringent regulatory standards and internal quality policies. You will lead a dedicated QA team, driving continuous improvement initiatives and maintaining the highest levels of product quality and patient safety. This is a strategic position for an experienced quality professional looking to make a significant impact within a leading pharmaceutical organization.

Key Responsibilities

• Develop, implement, and maintain comprehensive Quality Assurance (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-related activities, including batch record review, deviation management, CAPA implementation, change control, and internal/external audits.
• Ensure compliance with South African Health Products Regulatory Authority (SAHPRA) and other relevant international regulatory body guidelines.
• Conduct risk assessments and implement mitigation strategies to maintain product quality and patient safety.
• Act as the primary point of contact for regulatory inspections and customer audits, ensuring successful outcomes.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, or a related life science discipline; advanced degree preferred.
• Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Strong understanding of GMP, ICH guidelines, and regulatory compliance 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 pharmaceutical manufacturing environments.

Benefits

• Excellent annual salary commensurate with experience and leadership capabilities.
• Comprehensive benefits package, including medical aid and retirement fund contributions.
• Significant opportunities for professional development and career progression.
• Relocation assistance may be provided for suitable candidates.
• A commitment to a robust quality culture and continuous improvement in a key industrial hub.