Chemical Analyst - Port Elizabeth
Aspen Pharma Group
Job purpose 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. Responsibilities Planning and Operational Support Optimize and facilitate implementation of current processes. Propose changes or improvements to processes, tools, and techniques. Test Preparation Prepare and analyze 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. Utilize 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 results. 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 Awareness
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