Job Purpose:
- Responsible for testing and sampling of incoming raw material, packaging, bulk, semi-finished products, and manufactured products.
- Ensuring that manufactured products meet set quality standards.
Duties And Responsibilities:
On Sampling and Testing
- Perform sampling, testing and release of raw, packaging material, bulk, and semi-finished products and issue Certificate of Analysis to ensure quality of products meet a well-defined set of standards.
- Perform sampling, testing and approval of manufactured products: Liquid, solid and semi-solid products to ensure quality of products meet set standards.
- Conduct In-Process control in the Packaging/Manufacturing departments (testing at beginning, during and after stoppage of machines) and analyze test result, ensuring both packaging and manufacturing processes are conforming to quality standards.
On Material approval
- Review and approve Certificate of Analysis of materials to be purchased from suppliers.
- Issue Certificate of Analysis following set template and get approval of Quality Control Manager.
On System update and documentation
- Update system with all information included in the Certificate of Analysis and upon release of material.
- Update system with the bulk’s shelf life.
- Check status of all materials as per stock inventory sent by Quality Control Manager.
- Accurately document the results of the testing performed and properly maintain all documents and test records in a timely manner.
- Complete the Batch report with the needed quality information and submit to Quality Control Manager.
On Updating of quality procedures
- Assist in the writing and updating of Quality Control Procedures:
- Statistical Procedures
- Analysis Procedures
- Raw Materials analysis
- In process Testing
- Finished products analysis
- Microbiological analysis
- Stability Studies and protocols for raw materials and finished products
- All other Quality Control Procedures including environment
- Participate in the construction and/or revision of SOPs for the quality function
On Equipment monitoring and calibration
- Monitor QC equipment to ensure proper operation and calibration.
- Coordinate calibration of all test equipment and fixtures.
- Conduct Cleaning and Analytical Validation of equipment and machines to ensure quality standards are implemented.
On Inventory
- Monitor Reagents, Glassware and Standards inventory to ensure healthy stock levels.
- Execute and fill in Test Method Transfer protocols as per Licensor’s requirements.
On Customer complaint
- Participate in investigations following any received complaint, evaluate problems and make initial recommendations for possible corrective action
On Returns
- Handle the recall of products process.
On Reporting
- Prepare reports and submit to Quality Control Manager for review and approval:
- Out of specification Report, OOS
- Out of Trend Report, OOT
- Deviation Incident Report
- Change control or risk assessment report
Education:
- Bachelor's Degree in Chemistry or Biochemistry
Experience:
- Up to 1 year of Lab Experience