Senior Pharmaceutical Quality Assurance Manager

Placements24; Durban; Vor Ort; ZAR 1.200.000 - 1.800.000; Vollzeit

Benefits dieser Stelle

Private medical aid

Life insurance

Retirement fund contribution

Relocation support

Zusammenfassung

Placements24 in Durban seeks a Senior Pharmaceutical Quality Assurance Manager to lead our QA function, ensuring products meet strict regulatory standards. You will develop and maintain the QMS, guide CAPA investigations, and drive continuous improvement.

Ideal candidates have 7+ years in pharma QA with 3+ years in management, deep GMP knowledge, and strong leadership to support SAHPRA, FDA, and EMA inspections.

Qualifikationen

• 7+ years in Quality Assurance within pharma.
• Minimum 3 years in a management role in QA.

Aufgaben

• Develop, implement, and maintain a robust QMS aligned with GMP/ISO.
• Oversee batch record review, product release, deviations, and CAPA management.
• Lead internal audits and support regulatory inspections (SAHPRA/FDA/EMA).
• Mentor QA team and drive a culture of quality and compliance.
• Manage vendor qualification and raw material quality.

Kenntnisse

QA leadership

Regulatory compliance

GMP knowledge

Audits & CAPAs

Process validation

Ausbildung

Master's or PhD in Pharmacy/ Chemistry/ Biology

Tools

Quality management software

Jobbeschreibung

About the Role

Our client, a distinguished pharmaceutical manufacturer based in Durban , is seeking an experienced and detail-oriented Senior Pharmaceutical Quality Assurance Manager. This leadership position is critical for ensuring that all pharmaceutical products manufactured meet the highest standards of quality, safety, and efficacy. You will be responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) in line with international regulatory standards. This role demands a proactive approach to quality control, risk management, and continuous improvement initiatives. The successful candidate will play a key role in upholding the company's reputation for excellence and compliance within the highly regulated pharmaceutical industry. This is a hands-on leadership role, vital to our operational success.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) to comply with GMP, ISO, and other relevant regulations.
• Oversee and manage all QA activities, including batch record review, product release, deviation investigations, and CAPA management.
• Conduct internal audits and support external regulatory inspections (e.g., SAHPRA, FDA, EMA).
• Lead and mentor the Quality Assurance team, fostering a culture of quality and compliance.
• Manage vendor qualification and ensure the quality of raw materials and components.
• Review and approve validation protocols and reports for manufacturing processes and equipment.
• Stay current with evolving regulatory requirements and industry best practices.
• Drive continuous improvement initiatives to enhance product quality and process efficiency.

Requirements

• Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 7 years of progressive experience in Quality Assurance within the pharmaceutical industry, with at least 3 years in a management role.
• In-depth knowledge of GMP regulations (e.g., SAHPRA, FDA, EMA) and quality management principles.
• Proven experience in managing audits, deviations, CAPAs, and change control processes.
• Strong leadership, communication, and interpersonal skills.
• Excellent analytical and problem-solving abilities.
• Experience with validation processes (process, equipment, cleaning) is essential.
• Proficiency in using quality management software and tools.

Benefits

• This position offers a highly competitive salary commensurate with experience, along with a comprehensive benefits package including private medical aid, life insurance, and a generous retirement fund contribution.
• Our client also provides ample opportunities for professional development, including attendance at international conferences and specialized training programs.
• The role is based in our modern Durban facility, offering a stable and professional working environment.
• Relocation assistance may be available for the right candidate.

We value our employees and are committed to fostering a culture of collaboration, innovation, and growth.