Quality Assurance Specialist - GMP

Placements24; Gqeberha; Hybrid; ZAR 420,000 - 640,000; Full time

Benefits offered by this job

Performance bonuses

Health and retirement benefits

Hybrid work model

Professional development and training

Supportive team focused on quality

Job summary

Placements24 in Port Elizabeth is seeking a meticulous Quality Assurance Specialist with GMP knowledge to ensure that all pharmaceutical processes and products meet the highest quality standards and regulatory requirements.

You will be involved in quality system management, batch record review, deviation investigations, and audit support in a hybrid role balancing remote work with essential on-site activities.

Qualifications

• 3+ years of experience in Quality Assurance within the pharmaceutical or regulated industry.
• Solid understanding of GMP regulations and quality management systems.
• Experience with batch record review, deviation management, and CAPA systems.
• Strong attention to detail, analytical skills, and problem-solving abilities.

Responsibilities

• Review and approve batch manufacturing records, ensuring GMP compliance and procedures.
• Investigate deviations, OOS results, and CAPA effectiveness, implementing corrective actions.
• Participate in internal and external audits, supporting audit readiness and responding to findings.
• Assist in qualification and validation activities for equipment, processes, and analytical methods.
• Ensure adherence to Quality Management System policies and procedures.
• Provide GMP-related training to manufacturing personnel as needed.

Skills

GMP knowledge

Batch record review

Deviation investigations

CAPA systems

Audit readiness

QMS compliance

Training on GMP

Education

Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related science

Job description

About the Role

Our client is looking for a meticulous Quality Assurance Specialist with strong Good Manufacturing Practice (GMP) knowledge to join their team in Port Elizabeth . This role is essential for ensuring that all pharmaceutical manufacturing processes and products adhere to the highest quality standards and regulatory requirements. You will be involved in quality system management, batch record review, deviation investigations, and audit support. This hybrid position allows for effective integration of remote work capabilities with necessary on-site activities, providing a balanced and productive work experience. You will contribute to maintaining product integrity and patient safety through rigorous quality oversight.

Key Responsibilities

• Review and approve batch manufacturing records, ensuring compliance with GMP and approved procedures.
• Investigate deviations, Out-of-Specification (OOS) results, and CAPA effectiveness, recommending and implementing corrective actions.
• Participate in internal and external audits, supporting audit readiness and responding to audit findings.
• Assist in the qualification and validation activities for equipment, processes, and analytical methods.
• Ensure adherence to company Quality Management System (QMS) policies and procedures.
• Provide training to manufacturing personnel on GMP principles and quality-related topics as needed.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related science field.
• Minimum of 3 years of experience in Quality Assurance within the pharmaceutical or related regulated industry.
• Solid understanding of GMP regulations and quality management systems.
• Experience with batch record review, deviation management, and CAPA systems.
• Strong attention to detail, analytical skills, and problem-solving abilities.
• Comfortable working in a hybrid model, demonstrating adaptability and effective communication.

Benefits

• Competitive annual salary and potential for performance bonuses.
• Comprehensive health and retirement benefits.
• Hybrid work model that combines remote flexibility with essential on-site responsibilities in Port Elizabeth .
• Opportunities for professional development and training in pharmaceutical quality assurance.
• A supportive team environment focused on quality and compliance.