Job Description Version. no. : 01
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.
