Lab Quality Reviewer Analyst

Aspen Pharma Group
Gqeberha
ZAR 200 000 - 300 000
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.

Skills Required

Background/experience


  • 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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