Officer

23 hours ago

Ankleshwar, Gujarat, India Cadila Pharmaceuticals Full time


• To maintain and adherence of the GLP and safety procedures in laboratory.
• To raise the request for issuance of work data sheet / protocols.
• To perform the analysis as per work allocation and records the results in work sheet / protocol and maintain on line documentation.
• To maintain the CFR 21 part -11 compliance by following laid down procedures.
• To perform all the HPLC related analysis of In-process, finished products & returned goods / Hold time / Stability study /reference / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section – Head.
• To ensure that every specification and method of analysis used of right product/material code.
• To report any QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge.
• Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag.
• To record and ensure all the entries and results are in line with current specifications and STPs.
• To ensure column performance and column entry are maintain in column logbooks.
• To maintain instruments log books properly as per analysis.
• To acquire training from concerned person to update the cGMP system update technical knowledge.
• To record analytical data in work data sheets / protocols for raw material / packing materials/intermediates/in process/APIs and etc. as per current specification and method of analysis.
• To maintain reference / working standard/impurity standard usage records.
• To maintain instrument history record.
• Joint analysis with R&D personnel during analytical method transfer on HPLC.
• To perform analysis of stability samples as per stability schedule.

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