Job Description:

Principal Tasks &Responsibilities;
Quality Control analysis :
• To maintain and adherence of the GLP and safety procedures in laboratory.
• To raise the request for issuance of work data sheet / protocols.
• Allocate the work to analyst as per planning.
• To ensure that every specification and method of analysis used of right product/material code.
• To follow the instruction of Shift /Section In charge for analysis /planning.
• To report any QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge.
• To ensure all the entries and results are in line with current specifications and STPs.
• To prepare standard operating procedures, work data sheets and other documents related to QC.
• To ensure the all column performance and column entry are maintain in column logbooks.
• To maintain instruments log books properly as per analysis.
• To provide training to concerned person to update the cGMP system update technical knowledge.




• To ensure that analytical data in work data sheets / protocols for raw material /intermediates /APIs and etc... As per current specification and method of analysis.
• To ensure reference / working standard/impurity standard usage records.
• Review of in-process, Intermediate, Raw material, analytical data and approval for further processing of the batch.
• To ensure that the maintain of instrument history record.
• To ensure Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area.
• To be plan holding time study of intermediates and preparation of reports.
• To prepare/ check the protocols & reports for analytical method validation and analytical method transfer
• Inform and Investigate OOS results in RM/Intermediates/APIs
• Initiation of change control / deviations / NQI / QI/OOT related to QC.
• Ensure that all documents / records required for Regulatory Compliance are maintained properly.
• Review of SOP’s for regulatory compliance and a

📌 Manager (Ankleshwar)
🏢 DigiCAD
📍 Ankleshwar