Chemical Analyst
2 weeks ago
Perform QC and stability tests on raw materials, in-process and finished products, components & water to ensure quality and compliance.
Review compliance of products to GMP, quality standards and product specifications. Provide services according to Production plan.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
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 inprocess 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
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