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Officer

Cadila Pharmaceuticals Limited

0 years

0 Lacs

Ankleshwar Gujarat India

Posted:2 days ago| Platform:

Apply

Skills Required

training data analysis stability monitoring recording initiation compliance integration report test lims

Work Mode

On-site

Job Type

Full Time

Job Description

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 /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 ADL personnel during analytical method transfer on HPLC.
To perform analysis of stability samples as per stability schedule
Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area.
Inform and Investigate OOS results in Intermediate/ Finish /stability study.
Initiation of change control / deviations / NQI / QI/OOT related to QC.
Ensure CFR 21 part -11 compliance and follow good laboratory practices followed during analysis and ensure proper integration and online and periodic review for analysis data electronic data to maintain proper data integrity.
Ensure that all documents / records required for Regulatory Compliance are maintained properly.
Ensure timely report and completion of NQI, OOS, OOT, deviation, customer / market complaint investigation and change control.
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 i.e. In-process / Intermediate/ finished products / returned goods / Hold time / Stability study and working standard analysis as per laid down specification & test procedures , SOPs, record the analytical data in LIMS modules and report to Section – Head.
Wash the HPLC Column with appropriate solvent .
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.

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Cadila Pharmaceuticals Limited

Pharmaceuticals

Ahmedabad

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