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

 Skills Required

Background/experience

• National Diploma in Analytical Chemistry
• 2+ years 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