QA Analyst at HRLeverage Africa

Job Summary

• The QA Analyst will be responsible for ensuring that products are manufactured and tested in compliance with regulatory standards and internal quality procedures.
• This role involves the review and approval of manufacturing processes, documentation, and product quality to ensure the highest standards are maintained.

Key Responsibilities
Quality Systems Management:

• Develop, implement, and maintain quality systems and processes in accordance with GMP and regulatory requirements.
• Ensure compliance with internal and external quality standards, including FDA, WHO, and other regulatory requirements.

Documentation and Record Review:

• Review and approve batch records, production records, and other GMP documentation.
• Maintain accurate and detailed records of all quality-related activities and ensure proper documentation control.

Process and Product Audits:

• Conduct internal audits of manufacturing processes and systems to ensure compliance with SOPs, GMP, and regulatory requirements.
• Participate in external audits and inspections conducted by regulatory bodies.

Deviation and CAPA Management:

• Investigate deviations and non-conformances, determine root causes, and implement corrective and preventive actions (CAPAs).
• Monitor the effectiveness of CAPAs and report on their status.

Change Control:

• Manage and document changes to manufacturing processes, equipment, and systems.
• Assess the impact of changes on product quality and regulatory compliance.

Training:

• Develop and deliver training programs on GMP, quality systems, and regulatory requirements.
• Ensure all staff are adequately trained and maintain training records.

Quality Improvement:

• Identify areas for continuous improvement in quality systems and processes.
• Implement quality improvement initiatives and monitor their effectiveness.

Risk Management:

• Conduct risk assessments related to product quality and manufacturing processes.
• Develop and implement risk mitigation strategies.

Complaint Handling:

• Investigate product complaints and coordinate with relevant departments to resolve issues.
• Maintain records of complaints and report trends to management.

Supplier Quality Management:

• Evaluate and approve suppliers and contractors.
• Conduct audits and monitor the performance of suppliers to ensure compliance with quality standards.

Qualifications

• Education: Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field.
• Experience: At least 3-5 years of experience in a quality assurance role in the pharmaceutical industry.
• Technical Skills: Strong knowledge of GMP, GLP, and regulatory requirements. Experience with quality management systems and auditing.
• Soft Skills: Excellent attention to detail, strong analytical and problem-solving skills, effective communication, and ability to work independently and as part of a team.