Chemical Analyst (Port Elizabeth) needed at Aspen Pharma Group

Description
Overview

• 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

• 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 provided recommendations.
• Record, interpret and report testing results to management, including OOS results.

Requirements
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.