Pharmaceutical Quality Assurance Manager

Placements24

Bloemfontein

On-site

ZAR 900,000 - 1,500,000

Full time

3 days ago
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Benefits offered by this job

Salary with incentives
Healthcare coverage
Generous annual leave
Leadership development
Relocation assistance

Job summary

Placements24 seeks a Pharmaceutical Quality Assurance Manager to lead the QA unit in Welkom, overseeing the QMS to meet regulatory and internal quality standards. The role includes managing a team, driving continuous improvement, and ensuring GMP compliance in a manufacturing setting.

The ideal candidate has a Pharm/chemistry background with 8+ years in QA in pharma, including 3+ years in leadership, and a proven record in regulatory inspections and audits.

Qualifications

  • Bachelor's degree in a scientific field; Master’s preferred.
  • Minimum 8 years in Quality Assurance in pharma, with at least 3 years in management.
  • Extensive knowledge of pharmaceutical quality systems, GMP regulations, and validation principles.
  • Proven track record in regulatory inspections and audits.
  • Strong leadership, communication, and problem-solving skills.

Responsibilities

  • Develop, implement, and maintain the Quality Management System (QMS) per regulatory requirements.
  • Lead and manage the Quality Assurance team with guidance, training, and performance management.
  • Oversee QA activities: batch review, deviations, CAPA, change control, audits.
  • Ensure GMP compliance and regulatory guidelines through inspections and process improvements.
  • Act as primary QA contact for regulatory inspections and audits by health authorities and customers.

Skills

Leadership
Quality Assurance
GMP compliance
Regulatory inspections
CAPA & Change Control
Batch record review
Team management
Communication

Education

Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or related field
Master's degree

Job description

Our client is seeking an accomplished Pharmaceutical Quality Assurance Manager to lead their Quality unit in Welkom . This critical role involves overseeing all aspects of the quality management system to ensure our pharmaceutical products meet stringent regulatory standards and internal quality benchmarks. You will manage a team of quality professionals, drive continuous improvement initiatives, and ensure compliance with Good Manufacturing Practices (GMP). This is a senior leadership position for a dedicated quality expert committed to upholding the highest standards of product quality and patient safety within a manufacturing environment.

Key Responsibilities
  • Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with regulatory requirements.
  • Lead and manage the Quality Assurance team, providing guidance, training, and performance management.
  • Oversee all QA activities, including batch record review, deviation management, CAPA implementation, change control, and internal/external audits.
  • Ensure compliance with GMP and other relevant regulatory guidelines through regular inspections and process improvements.
  • Act as the primary quality contact for regulatory inspections and audits by health authorities and customers.
Requirements
  • Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or a related scientific field.
  • Master's degree preferred.
  • Minimum of 8 years of experience in Quality Assurance within the pharmaceutical industry, with at least 3 years in a management role.
  • Extensive knowledge of pharmaceutical quality systems , GMP regulations, and validation principles.
  • Proven track record in successfully managing regulatory inspections and audits.
  • Strong leadership, communication, and problem-solving skills.
Benefits
  • Attractive salary with performance-based incentives.
  • Comprehensive healthcare coverage, including medical, dental, and vision.
  • Generous annual leave and company-provided benefits.
  • Significant opportunities for career growth and leadership development.
  • Relocation assistance may be available for qualified candidates.
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