Description : CHEMICAL ANALYST. Company : Aspen Pharma Group. Location : Port Elizabeth, Eastern Cape
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 and 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 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
Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.
