QC Analyst

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
Post date: 17 July 2023
Publisher: Tanqeeb.com

Post date: 17 July 2023
Publisher: Tanqeeb.com