Chemical Analyst (East London) at Aspen Pharma Group

OBJECTIVE OF ROLE

• Perform quality control and stability testing on raw materials, in-process products, finished goods, components, and water to ensure compliance with established quality standards. Reviewed and verified product compliance with GMP requirements, quality standards, and product specifications. Provided quality support services in alignment with the production plan.

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

Requirements

EDUCATIONAL REQUIREMENTS

• Matric (Grade 12)
• National Diploma in Analytical Chemistry  

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• 2+ years’ laboratory experience

SOFT SKILLS AND COMPETENCY REQUIREMENTS

• Advanced understanding of pharmaceutical testing methods
• Understanding of pharmaceutical manufacturing and corrective action programs
• Experience on HPLC/GC and practical knowledge of Empower software
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objective
• Interrogating Information
• Meeting Deadlines
• Following Procedures
• Maintaining Accuracy
• Customer Awareness

COMPUTER SKILLS REQUIRED

• The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle.

DRIVERS LICENCE

• The successful candidate must have a valid driver’s licence and be able to travel as per the expectations of the role.