Senior Pharmaceutical Quality Assurance Manager

Placements24; Klerksdorp; Presencial; ZAR 900.000 - 1.700.000; Tempo integral

Benefícios oferecidos por esta vaga

Health insurance

Retirement fund

Performance bonus

Resumo da vaga

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Manager in Klerksdorp, North West to lead our client’s quality systems and ensure GMP/GDP compliance.

The role requires strong leadership, extensive QA experience, and deep regulatory knowledge to drive continuous improvement and uphold the integrity of life-saving medicines.

Qualificações

• Master’s degree in Pharmacy, Chemistry, Biology or a related scientific discipline with at least 7 years of progressive QA experience.
• Proven leadership experience and ability to manage QA teams and audits.
• Deep knowledge of GMP, GDP, regulatory standards, and QMS

Responsabilidades

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with GMP and regulatory standards.
• Lead and manage the QA team, provide direction, training and performance evaluations.
• Oversee internal and supplier audits and host regulatory inspections (e.g., SAHPRA, FDA).
• Manage deviations, CAPAs, change controls, and OOS investigations.
• Review and approve batch records, validation protocols and reports; ensure quality documentation.
• Ensure compliance with regulatory requirements and company policies.
• Support product lifecycle management from a quality perspective and drive continuous improvement.
• Foster a strong quality culture through training and initiatives.
• Coordinate with senior management and other departments on quality matters.
• Monitor quality metrics and prepare reports for leadership.

Conhecimentos

Leadership

Analytical thinking

Decision making

Communication

Quality software tools

Formação

Master's degree in Pharmacy, Chemistry, Biology, or related scientific discipline

Ferramentas

Quality Management Software

Descrição da vaga

About the Role

Our client, a distinguished pharmaceutical manufacturer renowned for its commitment to excellence, is seeking an accomplished Senior Pharmaceutical Quality Assurance Manager to lead their quality systems in Klerksdorp, North West. This pivotal leadership role will involve overseeing all aspects of the Quality Assurance, ensuring compliance with national and international pharmaceutical regulations (GMP, GDP, etc.). You will be responsible for maintaining and continuously improving the Quality Management System, driving audit readiness, and fostering a strong quality culture throughout the organization. This is an exceptional opportunity for a seasoned QA professional to take on significant responsibility and contribute to the integrity of life-saving medicines. The ideal candidate possesses extensive experience in pharmaceutical quality assurance, strong leadership skills, and a deep understanding of regulatory frameworks. We are looking for an individual who can effectively guide and inspire a team, uphold the highest standards, and drive continuous improvement. This role requires a dedicated professional who can ensure the robust performance of our client's operations in Klerksdorp, North West.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with GMP and other relevant regulatory standards.
• Lead and manage the QA team, providing direction, training, and performance evaluations.
• Oversee and conduct internal audits, supplier audits, and host regulatory inspections (e.g., SAHPRA, FDA).
• Manage deviations, CAPAs (Corrective and Preventive Actions), change controls, and OOS (Out of Specification) investigations.
• Review and approve batch records, validation protocols and reports, and other critical quality documentation.
• Ensure compliance with all applicable regulatory requirements and company policies.
• Contribute to product lifecycle management from a quality perspective.
• Champion a strong quality culture through training and continuous improvement initiatives.
• Liaise with senior management and other departments on quality-related matters.
• Monitor key quality metrics and prepare reports for senior leadership.

Requirements

• Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 7 years of progressive experience in pharmaceutical Quality Assurance, with at least 3 years in a management role.
• In-depth knowledge of GMP, GDP, and other relevant pharmaceutical quality standards and regulations.
• Proven experience in managing QMS, conducting audits, and handling regulatory inspections.
• Strong leadership, team management, and interpersonal skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Proficiency in quality management software and tools.
• Exceptional written and verbal communication skills.
• Experience with sterile manufacturing or complex dosage forms is a significant advantage.

Benefits

Our client offers an attractive salary package, comprehensive health insurance, retirement fund benefits, and a performance-driven bonus structure. Significant opportunities for professional growth, leadership development, and career advancement are available. Join a company that prioritizes quality and innovation, located in Klerksdorp, North West.