Lab Quality Reviewer Analyst

Findojobs South Africa; Oos-Kaap; On-site; ZAR 200,000 - 300,000; Full time

Job summary

A leading recruitment agency is looking for a Quality Assurance Specialist in South Africa to oversee lab quality reviews and optimize processes in line with quality standards. The role involves reviewing batch documentation, providing analytical support, and ensuring compliance with SOPs. Candidates should have relevant experience in quality assurance and a strong understanding of regulatory requirements.

Responsibilities

• Oversee work and/or serve as a lead technical expert.
• Optimize and facilitate implementation of current processes.
• Identify gaps in current policies and procedures.
• Propose changes or improvements to processes, tools, and techniques.
• Provide information for reports, as required by superiors.
• Provide analytical support in the absence of the Team Lead (TL).
• Support during regulatory audits.

Job description

Job Overview

• Review and approve batch documentation in line with SOP and quality standards.
• Perform lab quality review in line with SOP.
• Provide services according to Production plan.
• Handle related administrative tasks.

Responsibilities

Planning and Operational Support

• Oversee work and/or serve as a lead technical expert.
• Optimize and facilitate implementation of current processes.
• Identify gaps in current policies and procedures.
• Propose changes or improvements to processes, tools, and techniques.
• Provide information for reports, as required by superiors.
• Provide analytical support in the absence of the Team Lead (TL).
• Support during regulatory audits.

Lab Quality Review

• Perform Laboratory Quality Reviews (LQRs) according to Production plan.
• Review and approve lab records to ensure pharmaceutical analysis is carried out as per MOA; direct queries to laboratory.
• Electronically approve analytical results on relevant software, e.g., Empower.
• Evaluate and interpret chromatography data to ensure accuracy of results.
• Review and approve batch documentation compliance with SOPs and quality standards.
• Correct errors in batch documentation in line with GMP standards, SOPs, and product specifications.
• Record all Out-Of-Specification (OOS) investigations and conclusions, and report to management.
• Provide advice to analysts during laboratory investigations.
• Contribute to SOP updates.
• Ensure products are produced, tested, and stored according to SOPs and documentation.
• Ensure adherence by Analysts/Testers before product release.

Reporting and Record-Keeping

• Document and store data according to SOPs and regulations.
• Consolidate information for weekly/monthly reports.
• Analyze consolidated data and provide recommendations.
• Compile detailed and standardized reports and documents.
• Initiate deviations during review if discrepancies are identified.