Pharmaceutical Quality Assurance Manager

Placements24; Soweto; On-site; ZAR 900,000 - 1,500,000; Full time

Job summary

Placements24 in Soweto is seeking an experienced Pharmaceutical Quality Assurance Manager to lead the QA department. You will establish and maintain the QMS, ensure regulatory compliance, and safeguard product quality.

This senior role requires directing audits, handling deviation investigations, and driving continuous improvement. A relevant science degree and 8+ years in pharmaceutical QA are expected; leadership and communication skills are essential.

Qualifications

• Degree in Pharmacy, Chemistry, Biology, or related field; advanced degree preferred.
• 8+ years of progressive experience in pharmaceutical QA.
• Experience managing a QA department and leading audits.
• In-depth knowledge of GMP, regulatory affairs, and quality systems in the pharmaceutical industry.

Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with GMP, ISO, and other relevant regulations.
• Lead and manage the Quality Assurance team, providing guidance, training, and performance management.
• Oversee and conduct internal and external audits, including supplier qualification and regulatory inspections.
• Manage deviation investigations, change controls, CAPAs, and ensure timely resolution of quality issues.
• Review and approve batch release documentation, specifications, and validation reports.
• Stay current with evolving regulatory requirements and implement necessary updates to QMS and procedures.

Education

Pharmacy/Chemistry/Biology degree or related field

Job description

About the Role

Our client seeks an experienced and results-oriented Pharmaceutical Quality Assurance Manager to lead their Quality Assurance department in Soweto . This senior role is responsible for establishing and maintaining the company's Quality Management System (QMS), ensuring compliance with all relevant regulatory standards, and overseeing quality operations. You will manage a team of QA professionals, conduct audits, drive continuous improvement initiatives, and play a key role in safeguarding the quality and integrity of the company's pharmaceutical products. This is a critical leadership position within the organization.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with GMP, ISO, and other relevant regulations.
• Lead and manage the Quality Assurance team, providing guidance, training, and performance management.
• Oversee and conduct internal and external audits, including supplier qualification and regulatory inspections.
• Manage deviation investigations, change controls, CAPAs, and ensure timely resolution of quality issues.
• Review and approve batch release documentation, specifications, and validation reports.
• Stay current with evolving regulatory requirements and implement necessary updates to QMS and procedures.

Requirements

• Degree in Pharmacy, Chemistry, Biology, or a related scientific field; advanced degree preferred.
• Minimum of 8 years of progressive experience in pharmaceutical Quality Assurance.
• Proven experience in managing a QA department and leading quality audits.
• In-depth knowledge of GMP, regulatory affairs, and quality systems in the pharmaceutical industry.
• Strong leadership, decision-making, and problem-solving skills.
• Excellent communication and interpersonal abilities to effectively interact with all levels of the organization and regulatory bodies.

Benefits

• Highly competitive salary and bonus package.
• Comprehensive benefits including medical aid, retirement fund, and life assurance.
• Significant opportunities for professional growth and leadership development.
• A challenging and rewarding role within a reputable pharmaceutical company.
• Contribute to maintaining the highest standards of quality in pharmaceutical manufacturing in Soweto .