Senior QA Manager, Pharma Manufacturing – Durban

Placements24

Durban

On-site

ZAR 1,200,000 - 1,800,000

Full time

2 days ago
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Benefits offered by this job

Competitive salary with medical and (d
Dental coverage
Pension scheme
Performance-based bonuses
Professional development & conference
Collaborative and ethically driven环境
Travel assistance & wellness programs
Paid annual leave

Job summary

Placements24 represents a leading pharmaceutical manufacturer seeking an experienced Quality Assurance Manager to lead QA operations in Durban. This senior role focuses on establishing and maintaining the QMS, ensuring GMP and regulatory compliance, and driving continuous improvement across all departments.

Ideal candidates will have 10+ years in QA within pharma, with 5+ years in management, strong leadership, and deep knowledge of regulatory submissions and inspections.

Qualifications

  • Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 10 years in Quality Assurance within the pharmaceutical industry, with at least 5 years in a management or supervisory role.
  • Extensive knowledge of GMP, ICH guidelines, and regulatory submission requirements.
  • Proven experience in managing regulatory inspections (e.g., FDA, EMA, SAHPRA).
  • Strong understanding of pharmaceutical manufacturing processes, analytical testing, and quality control methodologies.
  • Excellent leadership, communication, problem-solving, and decision-making skills.
  • Demonstrated ability to build and lead effective teams.
  • Experience with quality risk management principles.
  • Proficiency in using quality management software and tools.
  • Adaptability to a fast-paced and evolving regulatory environment.
  • Must have legal authorization to work in Durban , KwaZulu-Natal.

Responsibilities

  • Develop, implement, and maintain a comprehensive Quality Management System (QMS) compliant with GMP, GDP, and relevant international standards.
  • Oversee all aspects of quality assurance, including quality control, batch release, deviation management, change control, and CAPA systems.
  • Lead and manage internal and external audits (regulatory inspections, customer audits, supplier audits).
  • Ensure compliance with all applicable regulatory requirements and guidelines pertaining to pharmaceutical manufacturing.
  • Develop and execute validation master plans and oversee validation activities for manufacturing processes, equipment, and analytical methods.
  • Manage the investigation of quality incidents, root cause analysis, and implementation of corrective and preventive actions.
  • Train and mentor QA staff and other personnel on quality standards, procedures, and regulatory requirements.
  • Monitor and report on key quality performance indicators (KPIs) to senior management.
  • Collaborate with cross-functional teams, including production, R&D, and regulatory affairs, to ensure quality is integrated throughout the product lifecycle.
  • Stay updated on evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.

Skills

Leadership
Strategic thinking
Quality mindset
Problem-solving
Decision-making
Team building

Education

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

Tools

Quality Management Software

Job description

Placements24 represents a leading pharmaceutical manufacturer seeking an experienced Quality Assurance Manager to lead QA operations in Durban. This senior role focuses on establishing and maintaining the QMS, ensuring GMP and regulatory compliance, and driving continuous improvement across all departments.

Ideal candidates will have 10+ years in QA within pharma, with 5+ years in management, strong leadership, and deep knowledge of regulatory submissions and inspections.

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