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Quality Control Manager Entirety Hr Solutions

5.0 - 10.0 years

6 - 10 Lacs

Ahmedabad

Work from Office

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.

Posted 19 hours ago

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