Deputy Manager-QC

Role overview

Sample analysis and laboratory work

• Analyze finished products, raw materials, stability samples, and related documentation in accordance with cGMP.
• Receive, store, and disposition QC samples after analysis; analyze vendor approval samples.
• Prepare and standardize volumetric solutions, reagents, and indicator solutions as needed.
• Operate HPLC methods only; access does not include method or report-format changes, run cancellations, or system or method configuration.

Records and compliance

• Document analytical records concurrently, store raw data, and enter usage information in instrument and equipment logbooks.
• Report deviations, incidents, OOT, or OOS immediately to the Section Head or Head of QC.
• Implement GLP and GMP requirements and maintain QC records such as laboratory notebooks, chromatograms, and certificates of analysis.
• Support the site Data Integrity Compliance Officer with monitoring and implementation of data integrity awareness actions.

Materials and team duties

• Arrange procurement of chemicals, reagents, standards, and columns for new projects.
• Maintain chemical-store bin cards and review laboratory chemicals.
• Allocate work to workmen and train them.
• Perform additional responsibilities assigned by the Section Head.

Division

Requirements

• Analyze finished products, raw materials, stability samples, and related documentation in accordance with cGMP.
• Operate HPLC methods as authorized; method changes, report-format changes, run cancellation, and system or method configuration are outside the stated access.
• Implement GLP and GMP requirements.
• Report deviations, incidents, OOT, or OOS immediately to the Section Head or Head of QC.
• Maintain controlled QC laboratory records, including laboratory notebooks, chromatograms, and certificates of analysis.