Senior Pharmaceutical QA Leader – GMP & Compliance

Placements24

Cape Town

On-site

ZAR 900,000 - 1,500,000

Full time

3 days ago
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Benefits offered by this job

Bonuses
Benefits package
Retirement plan
Professional development
Relocation assistance

Job summary

Placements24 in Cape Town is seeking a Lead Pharmaceutical Quality Assurance Manager to oversee quality operations in the Western Cape. This hands-on leadership role requires driving GMP compliance across manufacturing and distribution, and building a robust QMS.

You will lead a QA team, manage deviations, CAPAs, audits, risk assessments, and regulatory inspections, while partnering with Production, R&D and Supply Chain to improve processes and patient safety.

Qualifications

  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related field.
  • 8+ years in pharmaceutical QA/QC with 3+ years in leadership.
  • Extensive knowledge of GMP/ICH and regulatory requirements.
  • Experience developing and implementing QMS.
  • Proven team leadership experience.
  • Experience with regulatory inspections and audits.
  • Proficiency in quality management software.
  • Ability to manage multiple priorities under pressure.

Responsibilities

  • Develop, implement, and maintain the company's QMS per GMP/ICH.
  • Lead the QA team with guidance, training, and performance management.
  • Oversee batch record review, deviations, CAPA, change control, and internal audits.
  • Ensure compliance with national and international pharma regulations and guidelines.
  • Conduct risk assessments and mitigate to ensure product quality and patient safety.
  • Manage external audits from regulators and customers.
  • Collaborate with Production, R&D, and Supply Chain to resolve quality issues and drive improvements.
  • Review and approve validation protocols and reports for manufacturing processes and equipment.
  • Monitor key quality metrics and report overall quality performance.
  • Stay updated on evolving regulatory requirements and industry best practices.

Skills

GMP knowledge
QA leadership
Regulatory inspections experience
Risk assessment

Education

Bachelor's or Master's in Pharmacy, Chemistry, Biology

Tools

Quality management software

Job description

Placements24 in Cape Town is seeking a Lead Pharmaceutical Quality Assurance Manager to oversee quality operations in the Western Cape. This hands-on leadership role requires driving GMP compliance across manufacturing and distribution, and building a robust QMS.

You will lead a QA team, manage deviations, CAPAs, audits, risk assessments, and regulatory inspections, while partnering with Production, R&D and Supply Chain to improve processes and patient safety.

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