Pharmaceutical Quality Assurance Manager

Placements24; Vereeniging; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Executive-level salary

Medical aid

Retirement fund

Performance incentives

Professional development opportunities

Job summary

Placements24 is seeking a seasoned Pharmaceutical Quality Assurance Manager to oversee quality systems and regulatory compliance in Vereeniging. You will lead QA professionals, drive robust processes, and foster a culture of quality across the organization.

The role requires a Bachelor's in a related field with 7+ years of pharma QA experience, plus strong GMP and regulatory knowledge, and demonstrated leadership abilities.

Qualifications

• Bachelor's degree or higher in a scientific field with strong QA exposure.
• 7+ years in pharmaceutical Quality Assurance, with leadership experience.
• GMP and regulatory knowledge (SAHPRA, FDA, EMA) and robust quality systems.

Responsibilities

• Develop, implement, and maintain the company's QMS in compliance with GMP and other regulations.
• Lead and manage internal and external audits, including supplier qualification audits and regulatory inspections.
• Oversee review and approval of batch records, validation protocols, and technical documentation.
• Manage deviation investigations, CAPA implementation, and change control processes.
• Provide quality oversight for manufacturing, laboratory operations, and other departments.
• Train and mentor QA staff, ensuring competency and adherence to quality standards.

Skills

QA leadership

GMP compliance

Audit management

Regulatory liaison

Education

Bachelor's degree in Pharmacy, Chemistry, Biotechnology or related field

Master's degree (advantage)

Job description

About the Role

Our client is seeking a seasoned and quality-driven Pharmaceutical Quality Assurance Manager to oversee their quality systems and compliance operations in Vereeniging . This leadership role is crucial for ensuring that all pharmaceutical products manufactured by the company meet the highest standards of safety, efficacy, and quality, in strict adherence to regulatory requirements. You will lead a team of QA professionals, implement robust quality processes, and champion a culture of quality throughout the organization. This position offers a significant opportunity to shape and maintain the quality framework of a growing pharmaceutical entity.

Key Responsibilities

• Develop, implement, and maintain the company's overall Quality Management System (QMS) in compliance with GMP and other relevant regulations.
• Lead and manage internal and external audits, including supplier qualification audits and regulatory inspections.
• Oversee the review and approval of batch records, validation protocols, and technical documentation.
• Manage deviation investigations, CAPA (Corrective and Preventive Actions) implementation, and change control processes.
• Provide quality oversight for manufacturing, laboratory operations, and other relevant departments.
• Train and mentor QA staff, ensuring competency and adherence to quality standards.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline. A Master's degree is an advantage.
• Minimum of 7 years of experience in pharmaceutical Quality Assurance, with significant experience in a management or leadership role.
• In-depth knowledge of GMP , regulatory requirements (SAHPRA, FDA, EMA), and quality systems.
• Proven experience in managing audits, deviations, CAPAs, and change controls.
• Strong leadership, decision-making, and problem-solving abilities.
• Excellent written and verbal communication skills, with the ability to effectively interact with all levels of the organization and regulatory agencies.

Benefits

• An executive-level salary and comprehensive benefits package, including medical aid, retirement fund, and performance incentives.
• Significant responsibility and the opportunity to make a substantial impact on the company's quality strategy.
• Professional development opportunities and support for continuing education.
• A stable and reputable company with a commitment to ethical practices and product quality.
• A challenging yet rewarding work environment focused on achieving excellence in pharmaceutical quality.