Lab Quality Reviewer Analyst

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Aspen Pharma Group
Gqeberha
ZAR 300 000 - 600 000
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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 advice to analysts during laboratory investigations
  • Provide input into SOPs
  • Ensure that products are produced, tested and stored according to the required SOPs 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 a 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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