Lab Quality Reviewer Analyst

Aspen Pharma Group; Gqeberha; On-site; ZAR 420,000 - 550,000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Assurance professional to oversee lab activities, ensuring compliance with quality standards and regulatory requirements. The successful candidate will review batch documentation, support audits, and analyze lab data while leveraging their technical knowledge and experience in analytical chemistry.

Qualifications

• 6+ years' experience in related fields.
• Strong technical knowledge of laboratory equipment and processes.

Responsibilities

• Review and approve batch documentation and lab records.
• Provide analytical support and oversee lab quality reviews.
• Document and store data according to SOPs and regulatory requirements.

Skills

Laboratory experience

Understanding of pharmaceutical manufacturing

Ability to interpret policies

Education

National Diploma in Analytical Chemistry

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
• Related administrative tasks
  
  

Responsibilities

Planning and Operational Support

• Oversees work and/ or serve as a lead technical expert
• Optimise 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 superior
• Provide analytical support in the absence of the TL
• Provide support during regulatory audits.
  
  

Lab Quality Review

• Perform LQRs according to Production plan
• Review and approve lab records to ensure pharmaceutical analysis has been carried out as per MOA; direct queries to laboratory
• Electronic approval of 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 OOS investigations and conclusions, and report to management
• Provide advise to analysts during laboratory investigations.
• Provide input into SOPs
• Ensure that products are produced, tested and stored according to the required SOP’s and documentation
• Ensure adherence by Analyst/ Tester before release
  
  

Reporting and Record-Keeping

• Document and store data according to SOPs and regulation
• Consolidate information for reports on weekly/ monthly basis
• Analyse consolidated data and provide recommendations
• Compile detailed and standardised reports and consolidated documents
• Initiate deviations once picked up during reviewing.
  
  

Background/experience

Skills Required

• National Diploma in Analytical Chemistry with 6+ years’ experience
• Laboratory experience
  
  

Specific Job Skills

• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives
• Strong technical knowledge and be competent in the use of all laboratory equipment, software and techniques.
  
  

Competencies

• Interrogating Information
• Following Procedures
• Maintaining Accuracy
• Customer Awareness
  
  

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