Quality Assurance Manager - Pharmaceutical Manufacturing

Placements24; Soweto; Sur place; ZAR 1 000 000 - 1 500 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Health insurance

Retirement benefits

Career development

Quality-focused environment

Paid time off

Résumé du poste

Placements24, a leading pharmaceutical manufacturer in South Africa, seeks a highly experienced Quality Assurance Manager to lead QA operations in Soweto, Gauteng. You will ensure manufacturing processes and products meet GMP, FDA, WHO standards and internal quality policies while driving a robust QMS.

You will oversee batch release, deviations, CAPA, audits, regulatory submissions, and training, partnering with production, regulatory affairs, and R&D.

Qualifications

• Bachelor’s degree in a life science with deep QA exposure.
• Minimum 8 years in pharmaceutical Quality Assurance and GMP.
• Proven experience leading QMS, audits and CAPA processes.
• Strong communication, leadership and risk-management skills.

Responsabilités

• Develop, implement, and maintain a comprehensive QMS compliant with pharmaceutical regulations.
• Oversee batch release, document control, change control, deviations, and CAPA management.
• Conduct internal and supplier audits to ensure GMP compliance.
• Review manufacturing batch records and validation reports for accuracy.
• Manage regulatory inspections and timely regulatory responses.
• Lead investigation of quality incidents and drive effective CAPA.
• Develop training programs on GMP and quality assurance.
• Monitor quality metrics and report to senior management.
• Foster a strong quality culture and stay updated on regulatory changes.
• Collaborate with production, regulatory affairs, and R&D.

Connaissances

QA leadership

Regulatory compliance

CAPA management

Audit oversight

GMP knowledge

Batch record review

Quality metrics

Training delivery

Regulatory inspections

Risk management

Formation

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

Outils

QMS software

Documentation control systems

Description du poste

About the Role

Our client, a reputable pharmaceutical manufacturer, is seeking a highly experienced and detail-oriented Quality Assurance Manager to lead their QA operations in Soweto, Gauteng. This role is pivotal in ensuring that all manufacturing processes and products meet stringent regulatory standards (e.g., GMP, FDA, WHO) and internal quality policies. You will be responsible for developing, implementing, and maintaining the Quality Management System (QMS), overseeing all QA activities including batch record review, audits, deviations, CAPA management, and regulatory submissions. The ideal candidate will possess a deep understanding of pharmaceutical quality assurance principles, regulatory compliance, and risk management. Your leadership will be crucial in fostering a strong quality culture throughout the organization and ensuring the integrity and safety of pharmaceutical products. You will collaborate closely with production, regulatory affairs, and R&D departments. This is a critical role demanding strong analytical skills, meticulous attention to detail, and excellent leadership capabilities to manage a team of QA professionals and drive compliance in a highly regulated environment. The successful candidate will ensure adherence to the highest industry standards.

Key Responsibilities

• Develop, implement, and maintain a comprehensive Quality Management System (QMS) compliant with pharmaceutical regulations.
• Oversee all QA activities, including batch release, document control, change control, deviations, and CAPA management.
• Conduct internal and external audits (supplier audits) to ensure compliance with GMP and other relevant standards.
• Review and approve manufacturing batch records, validation protocols, and reports.
• Manage regulatory inspections and ensure timely responses to regulatory agencies.
• Lead the investigation of quality incidents and product complaints, implementing effective corrective and preventive actions.
• Develop and deliver training programs on quality assurance and GMP to relevant personnel.
• Monitor key quality metrics and provide regular reports to senior management.
• Champion a strong quality culture throughout the organization.
• Stay updated with evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Minimum of 8 years of experience in Quality Assurance within the pharmaceutical manufacturing industry.
• Extensive knowledge of Good Manufacturing Practices (GMP) and relevant regulatory guidelines (e.g., FDA, SAHPRA).
• Proven experience in managing and implementing Quality Management Systems (QMS).
• Demonstrated experience with batch record review, deviation management, and CAPA processes.
• Strong understanding of pharmaceutical validation principles.
• Excellent leadership, team management, and decision-making skills.
• Exceptional analytical, problem-solving, and attention-to-detail capabilities.
• Strong written and verbal communication skills.
• Experience in managing regulatory inspections.

Benefits

• Highly competitive salary and performance-based incentives.
• Comprehensive health insurance and retirement benefits.
• Significant opportunities for career advancement and professional development in a growing pharmaceutical company.
• Exposure to advanced pharmaceutical manufacturing and quality control practices.
• A supportive and challenging work environment committed to quality and patient safety.
• Generous paid time off and holiday schedule.