Quality Assurance Specialist - GMP Compliance

Placements24; Gqeberha; Hybrid; ZAR 350,000 - 550,000; Full time

Benefits offered by this job

Hybrid work

Career advancement

Competitive benefits

Job summary

Placements24 is seeking a dedicated Quality Assurance Specialist for its Port Elizabeth pharmaceutical operation. The role focuses on GMP compliance, audits, deviation investigations, and continuous quality improvement.

The position is hybrid, emphasizing oversight of quality systems at the Eastern Cape facility. Ideal candidates hold a Bachelor’s degree in a relevant science with a minimum of 3 years QA/QC experience in pharma, strong GMP knowledge, and excellent attention to detail plus

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related science.
• At least 3 years in QA/QC in pharma with GMP experience.
• Strong knowledge of GMP regs and quality management systems.
• Experience with deviation management, CAPA, change control, and audits.
• Attention to detail, analytical skills, and good communication.

Responsibilities

• Conduct internal audits and support external regulatory inspections to ensure GMP compliance.
• Review and approve manufacturing batch records, validation documents, and other quality-related documentation.
• Investigate deviations, OOS results, and customer complaints, implementing corrective actions.
• Participate in the change control process, assessing impact on product quality and compliance.
• Develop and deliver GMP training to relevant personnel, fostering a quality-focused culture.

Skills

GMP compliance

Audit management

CAPA

Deviation handling

Regulatory documentation

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biology

Tools

QMS software

Document control system

Job description

About the Role

Our client seeks a dedicated Quality Assurance Specialist to ensure adherence to Good Manufacturing Practices (GMP) within their pharmaceutical operations in Port Elizabeth. This role is vital for maintaining the high standards of quality and compliance required in the pharmaceutical industry. You will be involved in audits, inspections, documentation review, and continuous improvement initiatives to uphold product quality and regulatory compliance. This hybrid position allows for flexibility while ensuring critical oversight of quality systems at the Eastern Cape facility.

Key Responsibilities

• Conduct internal audits and support external regulatory inspections to ensure GMP compliance.
• Review and approve manufacturing batch records, validation documents, and other quality-related documentation.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective actions.
• Participate in the change control process, assessing the impact of changes on product quality and compliance.
• Develop and deliver GMP training to relevant personnel, fostering a quality-focused culture.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 3 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Strong understanding of GMP regulations and quality management systems.
• Experience with deviation management, CAPA, change control, and audit processes.
• Excellent attention to detail, strong analytical skills, and effective communication abilities.

Benefits

• Competitive salary and comprehensive benefits package.
• Hybrid work arrangement offering flexibility and work-life balance.
• Opportunities for career advancement within a growing pharmaceutical company.
• Exposure to various aspects of pharmaceutical quality management.
• A supportive work environment focused on quality and compliance in Port Elizabeth.