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Officer

Cadila Pharmaceuticals Limited

0 years

0 Lacs

Ankleshwar Gujarat India

Posted:2 days ago| Platform:

Apply

Skills Required

data analysis compliance stability test report lims calibration schedule documentation training

Work Mode

On-site

Job Type

Full Time

Job Description

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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Cadila Pharmaceuticals Limited

Pharmaceuticals

Ahmedabad

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