Senior Quality Assurance Manager

Placements24; Durban; Híbrido; ZAR 900.000 - 1.400.000; Jornada completa

Descripción de la vacante

Placements24 is seeking a Senior Quality Assurance Manager for a prominent pharmaceutical company in Durban, KwaZulu-Natal. The role oversees the QMS, regulatory compliance, audits, CAPA, and batch release to ensure product quality and regulatory adherence.

Hybrid work allows on-site supervision with flexible arrangements. The ideal candidate has 8+ years in pharmaceutical QA, strong leadership, and deep knowledge of cGMP/ICH guidelines, with proven QA team management and QMS development

Descripción del empleo

About the Role

Our client, a prominent pharmaceutical company renowned for its commitment to quality and innovation, is seeking a seasoned Senior Quality Assurance Manager to oversee quality operations in Durban, KwaZulu-Natal . This is a strategic position responsible for maintaining and enhancing the company's robust quality management system, ensuring compliance with all national and international regulatory standards. The ideal candidate will possess a deep understanding of pharmaceutical quality assurance principles and a proven track record in managing quality systems within a regulated environment. This role involves a hybrid work arrangement, offering flexibility while ensuring critical on-site oversight and collaboration within our Durban, KwaZulu-Natal facility.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with cGMP and other relevant regulations.
• Oversee and manage all quality assurance activities, including audits (internal and external), change control, deviation management, CAPA, and batch record review.
• Lead and mentor the Quality Assurance team, providing guidance and support to ensure high performance and professional development.
• Conduct regular internal audits to assess compliance and identify areas for improvement.
• Manage and host regulatory agency inspections and customer audits, ensuring successful outcomes.
• Review and approve critical quality documents, including validation protocols, IQ/OQ/PQ, and SOPs.
• Monitor quality metrics and KPIs, reporting on trends and recommending corrective actions.
• Ensure all pharmaceutical products meet defined quality standards and regulatory requirements before release.
• Stay abreast of evolving regulatory landscapes and implement necessary updates to the QMS.
• Collaborate with other departments to foster a company-wide culture of quality excellence.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
• Proven experience in managing and leading QA teams.
• Demonstrated expertise in developing and implementing QMS, including audit programs, deviation management, and CAPA systems.
• Strong understanding of pharmaceutical manufacturing processes and analytical testing.
• Excellent leadership, communication, and interpersonal skills.
• High level of attention to detail and strong analytical and problem-solving capabilities.
• Ability to effectively manage multiple priorities and projects in a deadline-driven environment.
• Experience with electronic QMS (eQMS) is advantageous.

Benefits

Our client offers an attractive compensation package, including a competitive base salary, significant annual bonus opportunities, and comprehensive benefits. These include a top-tier medical aid plan, a substantial provident fund, and generous paid time off. Opportunities for professional growth and career advancement are core to our client's philosophy. Employees also have access to wellness programs and employee assistance services. Join our client in Durban, KwaZulu-Natal , and lead the charge in ensuring pharmaceutical excellence.