- 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.
- Optimize and facilitate implementation of current processes.
- Propose changes or improvements to processes, tools, and techniques.
- 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.
- 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.
- 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
- National Diploma in Analytical Chemistry with 2+ years experience
- Laboratory experience
- 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.
- Interrogating Information
- Meeting Deadlines
- Following Procedures
- Maintaining Accuracy
- Customer Awareness
