Pharmaceutical Quality Assurance Manager

Placements24; George; Sur place; ZAR 900 000 - 1 500 000; Plein temps

Avantages offerts par ce poste

Competitive salary package

Medical aid

Retirement fund

Professional development

Annual leave

Résumé du poste

Placements24 is seeking an experienced Pharmaceutical Quality Assurance Manager to lead the QA department in George. The role focuses on maintaining GMP-compliant operations, managing the QMS, and ensuring product quality across manufacturing and testing activities.

The ideal candidate will have 7+ years in pharmaceutical QA with at least 3 years in a managerial role, plus strong leadership, regulatory, and analytical skills to drive continuous improvement at the George facility.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, or Biology.
• Minimum 7 years in pharmaceutical QA, with 3+ years in a managerial role.
• Strong GMP/ICH/regulatory knowledge.
• Experience implementing and managing QMS elements (deviation control, CAPA, change control, audits).
• Proven leadership and people management skills.
• Familiarity with George regulatory landscape advantageous.

Responsabilités

• Oversee QA operations, including batch release, deviation handling, CAPA, change control, and audits.
• Lead and mentor the QA team, promoting a culture of quality.
• Review validation protocols and reports for equipment, processes, and analytical methods.
• Coordinate internal audits and regulatory inspections and customer audits.
• Ensure GMP compliance across manufacturing, packaging, and testing activities.
• Collaborate with Production, QC, R&D to embed quality in operations.
• Monitor quality metrics and report to senior management.
• Stay updated on regulatory changes and implement QMS updates.

Connaissances

Leadership

Regulatory knowledge

Quality systems

Analytical thinking

Communication

Formation

Bachelor's degree in Pharmacy, Chemistry, Biology

Master's degree (preferred)

Description du poste

About the Role

Our client, a distinguished pharmaceutical company, is seeking an experienced and diligent Pharmaceutical Quality Assurance Manager to lead their Quality Assurance department in George. This critical role ensures that all manufacturing and operational activities adhere to the highest standards of quality, regulatory compliance, and Good Manufacturing Practices (GMP). The ideal candidate will possess strong leadership capabilities and a comprehensive understanding of pharmaceutical quality systems. Joining our client means becoming part of a team dedicated to producing safe and effective medicines, contributing to public health initiatives within the Western Cape province. This is an exceptional opportunity for a seasoned QA professional to make a significant impact on a company committed to excellence. The position requires a dedicated presence at the George facility to effectively oversee and implement quality initiatives.

Key Responsibilities

• Develop, implement, and maintain a robust Quality Management System (QMS) in accordance with national and international regulations (e.g., SAHPRA, FDA, EMA).
• Oversee all QA operations, including batch record review and release, deviation management, CAPA implementation, change control, and complaint handling.
• Conduct internal audits and support external regulatory inspections and customer audits.
• Ensure compliance with GMP guidelines across all manufacturing, packaging, and testing activities.
• Manage and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement.
• Review and approve validation protocols and reports for equipment, processes, and analytical methods.
• Monitor key quality metrics and prepare regular quality reports for senior management.
• Collaborate with other departments (e.g., Production, QC, R&D) to ensure quality is integrated into all aspects of operations.
• Stay updated on regulatory changes and industry best practices, implementing necessary updates to the QMS.
• Serve as the primary point of contact for regulatory agencies regarding quality matters.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. A Master's degree is a plus.
• Minimum of 7 years of experience in pharmaceutical Quality Assurance, with at least 3 years in a managerial or supervisory role.
• Extensive knowledge of GMP, ICH guidelines, and regulatory requirements for pharmaceutical manufacturing.
• Proven experience in implementing and managing QMS elements such as deviation control, CAPA, change control, and audits.
• Strong leadership, team management, and decision-making skills.
• Excellent analytical, problem-solving, and organizational abilities.
• Effective communication and interpersonal skills, with the ability to interact with all levels of the organization and regulatory bodies.
• Experience with validation processes (process, equipment, cleaning) is essential.
• Familiarity with the pharmaceutical landscape in George and surrounding areas is advantageous.

Benefits

• Highly competitive salary package and potential for performance bonuses.
• Comprehensive medical aid, retirement fund, and life insurance benefits.
• Opportunities for advanced training, professional development, and conference attendance.
• Generous annual leave and paid sick leave.
• A leadership role within a reputable and growing pharmaceutical company.
• Access to modern facilities and advanced pharmaceutical technologies.
• Supportive management and a strong emphasis on employee well-being.