Quality Assurance Specialist - GMP Compliance

Placements24; Pretoria; Hybrid; ZAR 550,000 - 850,000; Full time

Benefits offered by this job

Competitive salary

Medical benefits

Retirement benefits

Flexible hours

Remote work policy

Job summary

Placements24 in Pretoria seeks a meticulous Quality Assurance Specialist focused on GMP compliance to strengthen the QA unit. The role involves maintaining the QMS, conducting audits, and ensuring documentation supports product quality and patient safety.

You will lead deviations investigations, CAPAs, and training on GMP principles. This position offers remote work flexibility, with a capability to work from Pretoria as needed, and a clear path for regulatory and quality system excellence.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum 3 years of experience in a Quality Assurance or Quality Control role within the pharmaceutical industry.
• In-depth knowledge of Good Manufacturing Practices (GMP) and relevant regulatory guidelines (e.g., SAHPRA).
• Experience with QMS implementation, audits, and deviation management.
• Strong documentation and record-keeping skills.
• Excellent analytical and problem-solving abilities, with meticulous attention to detail, working remotely or in Pretoria.

Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in line with GMP guidelines.
• Conduct internal and external audits of suppliers, contract manufacturers, and internal processes.
• Review and approve batch records, validation protocols, and other quality-related documents.
• Investigate deviations, implement corrective and preventive actions (CAPAs), and track their effectiveness.
• Ensure all quality-related activities are compliant with local and international regulatory requirements.
• Provide training to personnel on GMP principles and quality procedures.

Skills

GMP compliance

Quality Assurance

Audits

CAPA management

Documentation

Analytical thinking

Education

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

Job description

About the Role

Our client is seeking a meticulous and experienced Quality Assurance Specialist with a strong focus on GMP compliance to join their Quality Unit in Pretoria . This vital role ensures that all pharmaceutical manufacturing and development activities adhere to stringent Good Manufacturing Practices (GMP) and regulatory standards. You will be responsible for maintaining and improving the Quality Management System, conducting audits, and managing documentation to guarantee product quality and patient safety. This is an excellent opportunity for a detail-oriented professional to make a significant impact on compliance and operational excellence within a reputable pharmaceutical organization. The role requires a proactive approach to quality assurance and a deep understanding of the pharmaceutical regulatory landscape.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in line with GMP guidelines .
• Conduct internal and external audits of suppliers, contract manufacturers, and internal processes.
• Review and approve batch records, validation protocols, and other quality-related documents.
• Investigate deviations, implement corrective and preventive actions (CAPAs), and track their effectiveness.
• Ensure all quality-related activities are compliant with local and international regulatory requirements.
• Provide training to personnel on GMP principles and quality procedures.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 3 years of experience in a Quality Assurance or Quality Control role within the pharmaceutical industry.
• In-depth knowledge of Good Manufacturing Practices (GMP) and relevant regulatory guidelines (e.g., SAHPRA).
• Experience with QMS implementation, audits, and deviation management.
• Strong documentation and record-keeping skills.
• Excellent analytical and problem-solving abilities, with meticulous attention to detail, working remotely or in Pretoria .

Benefits

• Competitive salary and annual performance bonus.
• Comprehensive medical and retirement benefits.
• Flexible working hours and a supportive remote work policy.
• Opportunities for professional growth and certifications in quality management.
• Engage with a forward-thinking Quality Assurance team focused on continuous improvement.