- To follow Data integrity policy, safety policy, cGMP, GDP and GLP procedures as applicable, while performing the assigned task
- To follow SOPs, Specifications, MoA and approved instructions while performing the activity
- Ensure the workbench's cleanliness, upkeep, glassware, instruments, and accessories essential for performing analytical activities. Initiate and complete allotted work within a specified timeline.
- Identify the scope of improving laboratory productivity and reducing errors
- To perform calibration and Qualification of laboratory instruments as per the SOP.
- To perform the Sampling and Labelling of Raw material, Water sampling, packing material, cleaning samples, Intermediate, Finished product, Swab sampling and Miscellaneous samples as applicable.
- Analysis of In-process, cleaning samples, Intermediate samples, finished products, API, Analytical method validations/transfer, Hold time studies, Stability samples and any other studies as per approved protocols/Specifications/SOPs.
- Should have the knowledge on handling of Instruments and software’s like HPLC, GC, Analytical balance, KF Auto titrator, FTIR, Polarimeter, UV-Spectrophotometer, pH/Conductivity meter, TOC etc.
- Reporting any abnormal observation identified during analysis to the reviewer/section head immediately.
- Disposal of left-over Sample after review/approval of analytical report /release.
- Responsible for performing Water sampling and Analysis.
- To organize to send samples to outside laboratories for testing.
- Packing and Maintenance of reserve samples and visual inspection of samples as applicable
- Disposal of left-over Sample after review/approval of analytical report /release.
- Maintenance of sampling tools as applicable
- Analysis and management of reference standards, workings standards etc.
- Recording of analytical observation/ findings, Reporting of data and results in Observation data sheets, forms, logbooks, LIMS and ELN application software’s
- Initiate and promptly participate in OOS, OOT, Deviations, Laboratory Incident, and laboratory errors.
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- Initiate and promptly participate in OOS, OOT, Deviations, Laboratory Incident, and laboratory errors.
- To complete all assigned mandatory training related to data integrity, health, and safety measures on time. To complete all the LMS training before due date
- In addition, Responsibility to maintain and handling of Laboratory Standards Includes:
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