Executive Quality Assurance Manager – Pharma Manufacturing

Placements24

Mbombela (Nelspruit)

On-site

ZAR 900,000 - 1,800,000

Full time

5 days ago
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Benefits offered by this job

Executive pay
Medical aid
Pension fund
Life insurance
Relocation assistance
Conferences
Annual leave
Wellness program
Leadership role
Tech access
Supportive environment
Career growth

Job summary

Placements24 in Nelspruit, Mpumalanga, seeks an experienced Quality Assurance Manager to lead the QA department, ensuring GMP compliance and regulatory alignment with SAHPRA, FDA, and EMA. You will develop and maintain the QMS, oversee audits, CAPAs, deviations, and drive continuous improvement to safeguard patient safety.

The role requires a Master’s/PhD in a life science, 8+ years in pharma QA, and strong leadership and communication skills.

Qualifications

  • Master's degree or PhD in Pharmacy, Chemistry, Microbiology, or a related life science field.
  • Minimum of 8 years progressive experience in Quality Assurance within the pharmaceutical industry.
  • Extensive knowledge of GMP, ICH guidelines, and regulatory requirements (SAHPRA, FDA, EMA).
  • Proven experience in developing and managing a comprehensive Quality Management System.
  • Strong leadership, team management, and decision-making skills.
  • Excellent analytical, problem-solving, and communication skills.
  • Experience in managing regulatory inspections and audits.
  • Proficiency in quality risk management principles.
  • Ability to interpret complex regulatory documents and implement necessary changes.

Responsibilities

  • Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with GMP and regulatory requirements.
  • Lead and manage the Quality Assurance team, providing guidance and professional development.
  • Oversee internal and external audits, ensuring readiness and effective resolution of findings.
  • Manage deviation investigations, CAPA (Corrective and Preventive Actions), and change control processes.
  • Ensure all manufacturing processes and documentation comply with regulatory standards.
  • Review and approve batch records, validation protocols, and reports.
  • Monitor product quality and implement measures to prevent quality issues.
  • Stay abreast of regulatory changes and ensure the QMS remains current.
  • Liaise with regulatory authorities and facilitate inspections.
  • Promote a quality-focused culture throughout the organization.

Skills

Leadership
Strategic thinking
Analytical
Communication
Regulatory liaison

Education

Master's degree or PhD in Pharmacy, Chemistry, Microbiology, or related life science

Job description

Placements24 in Nelspruit, Mpumalanga, seeks an experienced Quality Assurance Manager to lead the QA department, ensuring GMP compliance and regulatory alignment with SAHPRA, FDA, and EMA. You will develop and maintain the QMS, oversee audits, CAPAs, deviations, and drive continuous improvement to safeguard patient safety.

The role requires a Master’s/PhD in a life science, 8+ years in pharma QA, and strong leadership and communication skills.

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