Jobs 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.

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Job Summary

• The QC Analyst will be responsible for performing routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples.
• This role ensures that all products meet the established standards of quality, purity, and efficacy.

Key Responsibilities
Sample Analysis:

• Conduct chemical and physical analysis of raw materials, in-process samples, finished products, and stability samples using techniques such as HPLC, GC, UV-Vis, FTIR, and titration.
• Perform microbiological testing where applicable.

Documentation:

• Maintain accurate and detailed records of all analytical results.
• Ensure proper documentation of all test results in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Prepare and review standard operating procedures (SOPs) and test methods.

Equipment Maintenance:

• Calibrate, validate, and maintain laboratory equipment to ensure proper functioning.
• Troubleshoot and resolve issues with laboratory instruments.

Compliance:

• Adhere to all safety, health, and environmental regulations.
• Ensure compliance with internal and external quality standards, including FDA, WHO, and other regulatory requirements.
• Participate in internal and external audits.

Continuous Improvement:

• Identify areas for process improvement within the QC laboratory.
• Implement and document changes to enhance quality control processes.

Team Collaboration:

• Work closely with production, quality assurance, and research and development teams to ensure product quality.
• Provide technical support and training to other laboratory staff.

Reporting:

• Prepare and present analytical reports and data summaries to management.
• Communicate any deviations or non-conformances observed during analysis.

Qualifications

• Education: Bachelor’s Degree in Chemistry, Biochemistry, Pharmacy, or a related field.
• Experience: At least 2-3 years of experience in a quality control laboratory in the pharmaceutical industry.
• Technical Skills: Proficiency in analytical techniques such as HPLC, GC, UV-Vis, and FTIR. Knowledge of GMP, GLP, and regulatory requirements.
• Soft Skills: Excellent attention to detail, strong problem-solving skills, effective communication, and ability to work independently and as part of a team.

Additional Requirements:

• Ability to work in a fast-paced environment and manage multiple tasks simultaneously.
• Strong organizational skills
• Strong organizational skills and ability to maintain accurate records.
• Willingness to work flexible hours, including weekends and holidays if necessary.