Quality Control Manager

Online Testing and Analysis

• Conduct online testing of incoming raw materials, intermediate products,

and finished goods.

• Ensure that all testing (sampling, analysis) is carried out in accordance

with standard operating procedures (SOPs) and approved methods.

2. Sampling and Methodology

• Ensure proper sampling procedures and adherence to validated methods

of analysis.

• Verify that all required tests are performed according to approved

protocols.

3. System and Quality Control

• Develop and implement systems to monitor and control the quality of

inputs and outputs.

• Maintain compliance with cGMP, GLP, and company-specific quality

requirements.

4. Instrument Calibration and Validation

• Ensure timely calibration and validation of laboratory instruments as per

scheduled timelines.

5. Training and Personnel Development

• Train the junior QC personnel in compliance with cGMP, analytical

methods, limit testing, and other related tasks.

• Periodically evaluate analyst performance and provide constructive

feedback.

6. Housekeeping and Equipment Maintenance

• Monitor and maintain the cleanliness of the department and laboratory

equipment in accordance with cleaning schedules.

7. Cost Management

• Manage and monitor QC-related expenses and costing.

8. Analytical Reporting

Confidential

• Prepare and review analytical reports based on testing data.
• Record and manage test results in the SAP system.

9. Documentation and Labelling

• Ensure proper labelling of instruments, reagents, retention samples,

working standards, and reference standards.

• Maintain all QC documentation as per QMS and regulatory requirements.

10. Method Development and Validation

• Develop new analytical methods and perform method verification and

validation activities.

11. SOP and QMS Compliance

• Prepare and review QC-related SOPs and methods of analysis in

compliance with the Quality Management System (QMS).

• Ensure adherence to GLP and internal audit standards.

12. Handling of Quality Events

• Manage and document quality events including:

CAPA (Corrective and Preventive Actions)

Deviations and change controls

Out of Specification (OOS) results

Out of Trend (OOT) analysis

Risk assessments

Lab incidents

13. Cleaning Validation

• Execute and document cleaning validation activities as per regulatory

guidelines.

14. Instrument Operation

• Operate laboratory instruments as per SOP and ensure their optimal

performance.