Job Description

Version. no.:


The Job Responsibilities of the position holder are :


Responsible for performing the analytical activities as per Analytical competency matrix (Format No.BDI-QCSG004F23) and On job training and Practical Demonstration for Chemical and Instrumentation (Format No.BDI-QCSG004F19).


Analysis of In process, SFG, Finished Goods, Raw material & stability sample, Analytical method validation/Verification, of OSD and LVP as per defined Protocol or procedure and related documentation as per GLP and GMP in time.


Responsible for receiving sample and their documentation.


Responsible Data entry in SAP.


Responsible for sending the sample to outside laboratory and ensure their analysis as per requirement from Outside Commercial Lab as and when required.


Calibration of instruments, as and when required.


Preparation of volumetric solution, reagent, and test solution, as and when required.


Ensuring the timely updation in the documents as per the Pharmacopeial amendments.


Responsible for maintaining the resource in the quality control department.


To ensure the compliance of the requirement of cGDP/cGDP and Data integrity while performing all activities in the laboratory.


Ensuring the Compliance to EPD Global Guidelines.


Facing internal and external audits and ensuring compliance.


Implementation of GLP / GMP requirements.


Coordinating and aligning the practices and procedures in line with the COBC requirements.


SOP training in Isotrain of self-train within stipulated time.


Any other task assigned by reporting manager.


In absence of the position holder, the sub-ordinate Executive / Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working.

Signatures

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Position holder


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Authorized by