Quality Assurance Manager - Pharmaceutical Manufacturing

Placements24; Bloemfontein; On-site; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Incentive program

Health insurance

Retirement fund

Annual leave

Professional development

Modern facilities

Job summary

Placements24 in Bloemfontein, SA, is seeking a highly qualified Quality Assurance Manager to lead QA operations in GMP-compliant manufacturing environments. The role focuses on developing, implementing, and maintaining the Quality Management System (QMS), driving continuous improvement and ensuring regulatory compliance.

The successful candidate will have a strong leadership track record, extensive QA experience in pharmaceutical manufacturing, and a meticulous attention to detail to safeguard

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or related.
• Minimum 7 years of QA in pharmaceutical manufacturing, with at least 3 years in a management role.
• In-depth knowledge of GMP regulations and guidelines (SAHPRA, FDA, EMA).
• Proven experience in developing and implementing QMS.
• Strong understanding of pharmaceutical manufacturing processes and quality control procedures.

Responsibilities

• Develop, implement, and maintain the QMS in accordance with GMP and regulatory standards.
• Oversee QA activities including batch release, deviation management, CAPA, and change control.
• Conduct internal audits and participate in external regulatory audits.
• Ensure manufacturing and laboratory activities comply with procedures and specs.
• Review and approve critical quality documents (batch records, SOPs).
• Lead and mentor the QA team to foster quality culture and improvement.
• Investigate quality incidents and implement corrective actions.
• Manage vendor qualification and ensure quality of procured materials and services.
• Stay updated on regulations and guidelines to ensure compliance.

Skills

Leadership

Quality systems

Audits

Regulatory knowledge

Problem solving

Stakeholder management

Education

Bachelor's degree in Pharmacy

Bachelor's degree in Chemistry

Job description

About the Role

Our client, a leading pharmaceutical manufacturer known for its commitment to quality and innovation, is seeking a highly qualified Quality Assurance Manager to lead their QA operations in **Bloemfontein, Free State, ZA**. This role is critical in ensuring that all manufacturing processes and products adhere to the highest quality standards and regulatory requirements, including Good Manufacturing Practices (GMP). You will be responsible for developing, implementing, and maintaining the Quality Management System (QMS), overseeing audits, managing deviations, and driving continuous improvement initiatives. The successful candidate will possess a strong leadership aptitude, a deep understanding of pharmaceutical quality systems, and a meticulous attention to detail. This is an excellent opportunity to join a reputable organization and play a key role in maintaining the integrity and safety of pharmaceutical products, contributing to our client's reputation for excellence.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with GMP and other relevant regulatory standards.
• Oversee and manage all QA activities, including batch release, deviation management, change control, CAPA, and complaint handling.
• Conduct internal audits and participate in external audits by regulatory authorities and customers.
• Ensure all manufacturing and laboratory activities comply with approved procedures and specifications.
• Review and approve critical quality documents, such as batch records, validation protocols, and SOPs.
• Lead and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement.
• Investigate quality incidents and implement corrective and preventive actions.
• Manage vendor qualification and ensure the quality of procured materials and services.
• Stay updated on relevant regulations and guidelines, ensuring organizational compliance.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• Minimum of 7 years of experience in Quality Assurance within the pharmaceutical manufacturing sector, with at least 3 years in a management role.
• In-depth knowledge of GMP regulations and guidelines (e.g., SAHPRA, FDA, EMA).
• Proven experience in developing and implementing QMS.
• Strong understanding of pharmaceutical manufacturing processes and quality control procedures.
• Excellent leadership, team management, and communication skills.
• Demonstrated ability to conduct and manage audits.
• Proficiency in deviation management, CAPA implementation, and change control processes.
• Strong analytical and problem-solving skills.

Benefits

• Competitive salary and performance-based incentive programs.
• Comprehensive health insurance and retirement fund.
• Generous annual leave and sick leave policies.
• Opportunities for professional development and leadership training.
• Access to modern manufacturing facilities and advanced technologies.
• A stable and reputable company with a strong commitment to employee growth.