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, 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:
a. Statistical Procedures
b. Analysis Procedures
c. Raw Materials analysis
d. In process Testing
e. Finished products analysis
f. Microbiological analysis
g. Stability Studies and protocols for raw materials and finished products
h. 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:
a. Out of specification Report, OOS
b. Out of Trend Report, OOT
c. Deviation Incident Report
d. Change control or risk assessment report

Education
Bachelor's Degree in Chemistry or Biochemistry. Masters in Pharmacology is a plus

Experience
Up to 1 year of relevant experience