Pharmaceutical Quality Assurance Manager - Upington

Placements24; Upington; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Retirement fund

Career advancement

Job summary

Placements24 seeks an experienced Quality Assurance Manager to lead quality systems and regulatory compliance at a pharmaceutical facility near Upington, Northern Cape. The role entails developing, implementing, and maintaining robust QMS, conducting audits, handling deviations, and ensuring compliance with GMP and regulatory standards.

The successful candidate will provide leadership to the QA team, ensure training on GMP and SOPs, and drive continuous improvement in quality across

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related science.
• Master's degree or relevant certification is a plus.
• Minimum 7 years in Pharmaceutical Quality Assurance with at least 3 years in management/supervision.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with pharmaceutical regulations.
• Oversee QA activities including batch record review, deviation management, CAPA, change control, and complaints handling.
• Conduct internal audits of manufacturing, lab, and warehouse operations to ensure compliance.
• Host regulatory authority inspections and customer audits.
• Provide leadership to the QA team and foster continuous improvement.
• Ensure personnel training on GMP, SOPs, and quality policies.

Skills

Leadership

Quality Assurance

Auditing

Regulatory knowledge

GMP/ICH

Education

Bachelor's degree in Pharmacy, Chemistry, Biology

Master's degree or relevant certification (plus)

Tools

Quality management software

Job description

About the Role

Our client, a growing pharmaceutical company, is seeking an experienced and proactive Quality Assurance Manager to oversee quality systems and compliance at their facility near Upington, Northern Cape . This hybrid role is crucial for ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy. You will be responsible for developing, implementing, and maintaining robust quality management systems, conducting audits, managing deviations, and ensuring compliance with regulatory requirements. The ideal candidate will possess a strong background in pharmaceutical quality assurance, leadership experience, and a thorough understanding of GMP and relevant regulations. This is an excellent opportunity to lead quality initiatives within a dynamic organization and contribute significantly to patient safety. You will champion a culture of quality throughout the organization.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with pharmaceutical regulations.
• Oversee and manage all quality assurance activities, including batch record review and release, deviation management, CAPA, change control, and complaint handling.
• Conduct internal audits of manufacturing, laboratory, and warehouse operations to ensure compliance.
• Host regulatory authority inspections and customer audits.
• Provide leadership and guidance to the QA team, fostering a culture of continuous improvement.
• Ensure that all personnel are adequately trained on GMP, relevant SOPs, and quality policies.
• Monitor key quality performance indicators (KPIs) and report on the state of quality to senior management.
• Collaborate with other departments (e.g., Manufacturing, R&D, Supply Chain) to resolve quality issues and implement improvements.
• Stay current with evolving regulatory requirements and industry best practices.
• Manage vendor qualification and auditing program.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• A Master's degree or relevant professional certification is a plus.
• Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance, with at least 3 years in a management or supervisory role.
• In-depth knowledge of GMP, ICH guidelines, and pharmaceutical regulatory requirements (e.g., SAHPRA).
• Proven experience in developing and implementing QMS, conducting audits, and managing deviations.
• Strong leadership, team management, and decision-making skills.
• Excellent analytical, problem-solving, and risk assessment abilities.
• Effective communication, negotiation, and interpersonal skills.
• Ability to work independently and collaboratively in a hybrid team environment.
• Proficiency in quality management software and Microsoft Office Suite.
• Experience with validation processes is desirable.

Benefits

• Our client offers a competitive salary, comprehensive health insurance, retirement fund, and opportunities for career advancement.
• You will work in a supportive environment with a commitment to employee development.
• This hybrid role based near Upington allows for a balance between remote oversight and on-site leadership.
• Join our dedicated team and contribute to ensuring the highest quality standards in pharmaceutical production.