Chemical Analyst at Aspen Pharma Group

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

Requirements:

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:

• Apply advanced knowledge of concepts, methods, terminology, codes, quality standards and specialised job requirements
• 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