Description

• 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

• Optimize and facilitate implementation of current processes.
• Propose changes or improvements to processes, tools, and techniques.

Test Preparation

• Prepare and analyze 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.
• Utilize 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 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