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 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 deadline
Following Procedures
Maintaining Accuracy
Customer Awareness
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