Chemical Analyst

**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

**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 SOP’s
- 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 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 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
- 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

**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

**Accountability & Decision Making**

**Responsible to**:

- 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

**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

**Reporting and Record-Keeping**
- Document and store data according to SOPs and regulation
- Consolidate information for reports on weekly/ monthly basis
- Record, interpret and report testing results to management, including OOS results