Aspen Pharma Group

Chemical Analyst

Port Elizabeth, Eastern Cape, ZA

Company: Aspen Pharma Group

Category: Life, Physical, and Social Science Occupations

Published on 2022-01-14T12:36:00.000000Z

  • Perform QC and stability tests on raw materials, in-process and finished products, components and water to ensure quality and compliance
  • Review compliance of products to GMP, quality standards, and product specifications
  • Provide services according to Production plan

Planning and Operational Support:

  • Optimise and facilitate implementation of current processes
  • Propose changes or improvements to processes, tools and techniques

Test Preparation:

  • Prepare and analyse samples according to SOPs
  • Prepare and operate laboratory equipment according to SOPs
  • Perform calibration checks on equipment according to calibration procedure, to ensure accurate results
  • Prepare reagents and solutions for testing
  • Maintain good housekeeping

Testing:

  • Perform HPLC/GC analysis using MOA
  • Perform routine analysis on in-process and final products, raw materials and components
  • Perform routine stability tests such as related substances, assay and dissolution to assess quality of product
  • Perform daily and weekly water testing according to SOP
  • Support testing for OOS investigations to establish any systematic issues in process or testing
  • Handle problems efficiently according to quality policy
  • Report feedback on services or outputs regularly to customers
  • Check HPLC/GC runs regularly during the shift
  • Provide internal customers with accurate HPLC/GC results
  • Propose, develop and update methods for improving customer service
  • Check, document and report operational output against actuals
  • Communicate deviations for production and process improvements
  • Utilise technology as per qualification requirements

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
  • Record, interpret and report testing results to management, including OOS result

Skills required Background/experience:

  • National Diploma in Analytical Chemistry with 2+ years experience
  • Laboratory experience

Specific job skills:

  • Advanced understanding of pharmaceutical testing methods
  • Understanding of pharmaceutical manufacturing and corrective action programs
  • Knowledge of Millennium Software (HPLC) and GC Software
  • Pharmaceutical standards and compliance requirements
  • Ability to interpret and implement policies, processes and objectives

Competencies:

  • Interrogating Information
  • Meeting Deadlines
  • Following Procedures
  • Maintaining Accuracy
  • Customer Awarenes

Accountability & Decision Rights Responsible to:

  • Apply advanced knowledge of concepts, methods, terminology, codes, quality standards and specialised job requirements
  • Provide updates to management on operational performance, work progress and quality

Decisions related to:

  • Correct and/ or contain errors of significant impact
  • Prioritise tasks and responsibilities within overall direction and clearly defined parameters/ schedules and established policies, practices, guidelines, and quality and safety checks.

Reporting lines / interfaces:

  • Reporting to: QC Team Leader
  • Direct reports: None
  • Supporting structures: None

 Deliverables:

  • Services are provided according to Production plan
  • Method of analysis (MOA) is used for the analysis
  • Problems are handled efficiently according to quality policy
  • Feedback on outputs is reported regularly to customers
  • HPLC/GC runs are checked regularly during the shift
  • Products comply to GMP and quality standards, and product specifications
  • Sampling and testing comply to GMP standards and SOPs
  • Equipment calibrated according to procedure
  • Internal customers provided with accurate HPLC/GC results
  • Technology is utilised competently as per qualification requirements
  • Good housekeeping maintained in lab
  • Documents recorded and stored according to regulation
  • Reports submitted on a weekly/ monthly basis

 

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